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

Stryker GmbH: Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S

Is my product affected?

Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S

  • UPC 04546540200105

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

What happened

Stryker GmbH is recalling one femoral nail (A/R T2 Femur 15x240 mm, Product Number 18251524S, Lot code K078C70) that was distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The manufacturer discovered that this product may have left the factory out-of-specification due to non-conforming cannulation of the nail, which could result in reduced component strength and potentially premature nail breakage.

The record does not specify a remedy or any action affected consumers should 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. Quantity: 1 Lot/code info: GTIN 04546540200105; Lot code: K078C70

Source

Official record: FDA (Device enforcement) ↗

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

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