FDA-Device2018-05-16Class II
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Zimmer Biomet, Inc.
Hazard
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.
Sold states
Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
Affected count
108
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2018Don't want to check this manually?
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