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

Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S — recall Z-2395-2018

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

As described by U.S. FDA — Device Enforcement: Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2395-2018
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Barcode (EAN/GTIN)
04546540199508
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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