French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a recall made by DiaSorin. The users concerned received the attached mail (17/04/2013) (54 KB).
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch withdrawal carried out by ConvaTec / Unomedical. The distributors and end-users concerned received one of the 2 letters enclosed (11/09/2017) (819 KB). This safety action is registered with the ANSM under the number R1708505, R1714395. Read auss. High concentration oxygen mask - Unomedical - Lo recall. (5/24/2017)
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a withdrawal of lots by the company APPLIED MEDICAL RESOURCES. The users concerned received the attached mail (29/05/2017) (587 KB). This safety action is registered at ANSM under the number R1708526.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch withdrawal carried out by Cook Incorporated. The users concerned received the attached mail (02/06/2017) (347 KB). This safety action is registered with the ANSM under the number R1708568.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of the withdrawal of a batch made by MAST Diagnostic. The affected users received the attached mail (30/05/2017) (368 KB). This safety action is registered at ANSM under the number R1708681.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal action carried out by Medacta International. The affected users have received the attached mail (01/06/2017) (647 KB). This safety action is registered at ANSM under the number R1708731.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Rod, fixation, intramedullary and accessories - Product Code HSB
Reason
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Action
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal action carried out by NEWDEAL. The users concerned have received the attached mail (06/06/2017) (217 KB). This safety action is registered at ANSM under the number R1708781.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a batch withdrawal carried out by the company MÖLNLYCKE HEALTH CARE AB .. The users concerned have received the attached mail (09/06/2017) (135 KB). This safety action is registered at ANSM under the number R1708783.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal carried out by BD. The affected users have received the attached mail (02/06/2017) (1678 KB). This safety action is registered with the ANSM under the number R1708785.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a lot withdrawal action carried out by the company MEDOS International SARL .. The users concerned have received the attached mail (13/06/2017) (125 KB). This safety action is registered at ANSM under the number R1708889.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a withdrawal of lots by the company Bentley InnoMed GmbH .. The users concerned have received the attached mail (08/06/2017) (1850 KB). This safety action is registered with the ANSM under the number R1708891.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Action
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal carried out by PHILIPS. The users concerned have received the attached mail (02/06/2017) (269 KB). This safety action is registered at ANSM under the number R1708900 / R1708886.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a withdrawal of batches made by INGEN .. The users concerned have received the attached mail (07/06/2017) (221 KB). This safety action is registered at ANSM under the number R1708932.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a batch withdrawal action carried out by the company ZIMMER BIOMET. The concerned users received the attached mail (08/06/2017) (256 KB). This safety action is registered at ANSM under the number R1708954.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a withdrawal of lots made by CREGANNA MEDICAL. The users concerned have received the attached letter (17/07/2017) (112 KB). This safety action is registered with the ANSM under the number R1709046.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a withdrawal of lots made by CREGANNA MEDICAL. The users concerned have received the attached mail (06/06/2017) (112 KB). This safety action is registered with the ANSM under the number R1709046.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Rod, fixation, intramedullary and accessories - Product Code HSB
Reason
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Action
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a batch withdrawal action carried out by MEDICREA INTERNATIONAL. The users concerned received the attached mail (12/06/2017) (176 KB). This safety action is registered at ANSM under the number R1709064.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a product withdrawal carried out by EOS Imaging. The users concerned have received the attached mail (08/06/2017) (128 KB). This safety action is registered with the ANSM under the number R1709066.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal action carried out by ZIMMER. The affected users have received the attached mail (12/06/2017) (433 KB). This safety action is registered with the ANSM under the number R1709094.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a batch recall carried out by Boston Scientific .. The users concerned have received the attached mail (14/06/2017) (36 KB). This safety action is registered at ANSM under the number R1709096.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
Extra notes in the data
Action
The ANSM has been informed of the implementation of a batch withdrawal made by Beckman Coulter. The users concerned have received the attached mail (14/06/2017) (328 KB). This safety action is registered at ANSM under the number R1709133.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Action
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.