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FDAFDA · Food and drugs·Recall number Z-2399-2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S

Published July 18, 2018 · Recall initiated: April 27, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Stryker GmbH
Distributor
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Lot
GTIN: 04546540200655; Lot code: K07AFF5
Risk classification
Class II
Area (FDA)
device
Country
Switzerland

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