Recall Z-1736-2018 ยท HWC Screw, Fixation, Bone
Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
| Date | Mar 28, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 53 |
| Distribution | Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041274 | RESORBABLE INTERFERENCE SCREW Arthrotek, Inc., Jul 28, 2004 |