Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
This recall has been terminated (originally issued March 28, 2018).
- Company
- Zimmer Biomet, Inc.
- Recall Initiated
- March 28, 2018
- Terminated
- March 29, 2019
- Recall Number
- Z-1737-2018
- Quantity
- 54
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Distribution
Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Lot / Code Info
lot 326920
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons. Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm. Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement. Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.