International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Event ID
52713
Event Risk Class
Class 3
Event Number
Z-2176-2009
Event Initiated Date
2009-06-26
Event Date Posted
2009-09-14
Event Status
Terminated
Event Country
United States
Event Terminated Date
2010-07-27
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83805
Notes / Alerts

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

Screw, fixation, bone - Product Code HWC
Reason
Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in astm standard for titanium surgical implants.
Action
Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Stryker Orthopaedics Cancellous Bone Screw

Model / Serial
Catalog number: 2030-6535-1; 6.5 CANCELLOUS BONE SCREW 35mm AHEMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm AHHMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm AHKMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm H8LMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm H8MMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm H8NMKE 21-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm LL7MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm MKDMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm MKEMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm MKAMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm MKHMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NNKMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NN3MKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NN2MKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NNEMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NN0MKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm NNHMKE 27-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm V1WMKE 29-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm V25MKE 29-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm V28MKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm V29MKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm VL8MKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm VL9MKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm VLAMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm W0HMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm W0LMKE 30-Jun-2013 6.5 CANCELLOUS BONE SCREW 35mm W0PMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm W0JMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm W0VMKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm V22MKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm W0WMKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 6DYMLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 6E2MLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 6E0MLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 8TNMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 8TWMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 8TTMLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm 8TRMLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm E3MMLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm AT8MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm AT4MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm AT6MLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm AT7MLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm EMTMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm EMNMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm JHXMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm E3LMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm E3KMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm JHWMLE 22-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm JJ0MLE 22-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm JN4MLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm LPPMLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm LPTMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm LPVMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm LPRMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm MR2MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm MR7MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm P22MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm P8TMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm P8WMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm P8XMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm P8YMLE 30-Jul-2013 6.5 CANCELLOUS BONE SCREW 35mm HWDMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm HWHMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm HWAMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K32MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K35MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K38MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K36MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K39MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm HW8MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm K37MME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 35mm 1AXMNE 07-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 1AYMNE 07-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 2A1MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 29KMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 29XMNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 269MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 1ATMNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 1D2MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 29PMNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 29TMNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 2A5MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 4MJMNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 4MKMNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 78DMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 78AMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 985MNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 987MNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm 983MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm AD7MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm ADAMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm AD8MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TN 13-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TM 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TP 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TL 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TH 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TR 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER5V4 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER5V7 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER4TJ 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER5V5 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER5V6 18-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER98T 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MER98V 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERAPH 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERAPM 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERANW 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERAPA 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERAP7 20-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERAP4 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERDD1 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERDD2 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MEREDD 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MEREDH 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERHNJ 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERHNL 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERHNK 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MERJA7 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 35mm MEREDE 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERP29 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERP2A 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERP2D 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERP28 08-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET31T 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET320 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET31X 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET31V 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET33P 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET31W 11-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERP8X 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERPDM 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERPDP 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERPDR 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MERPDN 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET6M5 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET722 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET6M4 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7MY 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7N1 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7N2 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET721 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7L5 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METE5R 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METE5P 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METEE9 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METEEE 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METEE8 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METEED 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7MX 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm MET7N5 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 35mm METN4E 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METN6K 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METMR8 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METMR9 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METP7J 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METNHH 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPA2 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPM1 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPTY 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METP7H 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METP7K 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPA3 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPTX 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METPTW 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA1WP 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA1WR 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA262 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA29T 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA261 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA260 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA29V 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MET31Y 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA542 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA55M 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA5LH 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA5LJ 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm MHA5LE 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 35mm METNKM 25-Jan-2014
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution
Product Description
Stryker Orthopaedics Cancellous Bone Screw; || Dia 6.5 mm; Lnth: 35 mm; Sterile: || Made in the USA; || Stryker Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
Manufacturer
Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Recall of Device Recall Stryker Orthopaedics Cancellous Bone Screw

What is this?

Device

Device Recall Stryker Orthopaedics Cancellous Bone Screw

Manufacturer

Stryker Howmedica Osteonics Corp.