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

Recall Z-2394-2018 — Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

U.S. FDA — Device Enforcement · Switzerland · 2018-04-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2394-2018
Date of alert
2018-04-27
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Stryker GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04546540199492
Reported risk: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
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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