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

Stryker GmbH: Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

Is my product affected?

Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S

  • UPC 04546540646842

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

What happened

Stryker GmbH is recalling Femoral Nail LEFT T2 GTN 12x360 mm (Product Number 18501236S) distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The manufacturer discovered that some products may have left the factory out of specification, with non-conforming cannulation of the nails that could result in reduced component strength and potentially premature nail breakage. The affected lot code is K081650.

The recall record does not specify a remedy or recommended action for consumers.

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: 04546540646842; Lot code: K081650

Source

Official record: FDA (Device enforcement) ↗

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

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