Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1945-2015 — Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures

U.S. FDA — Device Enforcement · United States · 2015-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1945-2015
Date of alert
2015-06-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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