Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Reported: May 16, 2018 Initiated: March 28, 2018 #Z-1735-2018
Product Description
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 108
- Distribution
- Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.. Recalled by Zimmer Biomet, Inc.. Units affected: 108.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1735-2018.
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