Device product
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Z-1736-2018
Product summary
- Event
- Event 79682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53
- Official record key
device-enforcement:Z-1736-2018
Official wording
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.
Code information: lot 326900
Distribution pattern: Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Derived failure modes
-
Unknown
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.