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FDA (Device enforcement)Recalled 2018-04-27closedclass ii

Stryker GmbH: Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S

Is my product affected?

Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S

  • UPC 04546540646583

Check against the official notice below — it lists the full affected range.

What happened

Stryker GmbH is recalling Femoral Nail, LEFT T2 GTN ¿10x360 mm (Product Number 18501036S, GTIN: 04546540646583, Lot code: K08D58D) distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The manufacturer discovered that potentially out-of-specification products may have left the factory with non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage.

The recall notice does not specify a remedy or actions for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA. Lot/code info: GTIN: 04546540646583; Lot code: K08D58D

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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