Events

Recall of VICRYL RAPIDE Suture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc..

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
    79086
  • Event Risk Class
    Class 2
  • Event Number
    Z-0693-2018
  • Event Initiated Date
    2017-08-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161312
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Reason
    On august 17, 2017, ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of vicryl rapidetm (polyglactin 910) suture that were distributed to the field. during finished goods testing, a suture damage was identified on a lot of vicryl rapidetm suture. during the course of the subsequent investigation, the suture also failed knot tensile strength testing.
  • Action
    On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax: " Online: www.fda.gov/medwatch/report.htm " Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 " Fax: 1-800-FDA-0178

Device

VICRYL RAPIDE Suture
  • Model / Serial
    Coated VICRYL RAPIDETM (Polyglactin 910) Suture MPVR4260H Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031149168 Coated VICRYL RAPIDETM (Polyglactin 910) Suture V2140H Size 4-0 VICRYL RAPIDE Undyed 70cm RB-1 Needle 10705031106048 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2217 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031119925 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2253 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031119956 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2279 Size 4-0 VICRYL RAPIDE Undyed 75cm V-4 Needle 10705031086524 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2294 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-3 Needle 10705031086548 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2297 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031119970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR496 Size 4-0 VICRYL RAPIDE Undyed 18'' PS-2 Needle 10705031134690 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR945 Size 2-0 VICRYL RAPIDE Undyed 36'' CT-1 Needle 10705031133358 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI253H Size 2-0 VICRYL RAPIDE Undyed 75cm FS-1 Needle 10705031111172 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9941 Size 2-0 VICRYL RAPIDE Undyed 75cm FS Needle 10705031130999 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR426 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031134669 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR494 Size 4-0 VICRYL RAPIDE Undyed 45cm P-3 Needle 10705031134683 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR845 Size 4-0 VICRYL RAPIDE Undyed 45cm PC-3 Needle 10705031134744 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR917 Size 2-0 VICRYL RAPIDE Undyed 90cm V-34 Needle 10705031134768 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2286 Size 2-0 VICRYL RAPIDE Undyed 90cm FSL Needle 10705031080256 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VR2299 Size 2-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031080294 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9918 Size 4-0 VICRYL RAPIDE Undyed 75cm PC-3 Needle 10705031151970 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9930 Size 4-0 VICRYL RAPIDE Undyed 75cm FS-2 Needle 10705031152007 Coated VICRYL RAPIDETM (Polyglactin 910) Suture FH1642H Size 4-0 VICRYL RAPIDE Undyed 45cm FS-2 Needle 10705031099968 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI214H Size 4-0 VICRYL RAPIDE Undyed 75cm RB-1 Plus Needle 10705031111127 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI312H Size 2-0 VICRYL RAPIDE Undyed 75cm SH-1 Plus Needle 10705031111264 Coated VICRYL RAPIDETM (Polyglactin 910) Suture VRI417H Size 2-0 VICRY RAPIDE Undyed 75cm SH Plus Needle 10705031111332 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9922 Size 4-0 VICRYL RAPIDE Undyed 75cm PS-2 Needle 10705031130845 Coated VICRYL RAPIDETM (Polyglactin 910) Suture W9933 Size 2-0 VICRYL RAPIDE Undyed 75cm PS Needle 10705031130937
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationally
  • Product Description
    Coated VICRYL RAPIDETM (Polyglactin 910) Suture
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., Us Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA