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

Recall Z-1600-2015 — TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

U.S. FDA — Device Enforcement · United States · 2015-04-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1600-2015
Date of alert
2015-04-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes, Inc.
Product category
device
Product type
Devices
Reported risk: TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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