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

Stryker GmbH: Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

Is my product affected?

Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S

  • UPC 04546540199775

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

What happened

Stryker GmbH is recalling 9 units of Femoral Nail, A/R T2 Femur 12x360 mm (Product Number 18251236S, Lot code K081650) distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The manufacturer discovered that some products may have left the factory with out-of-specification cannulation, which could reduce component strength and potentially cause premature nail breakage.

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

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: 9 Lot/code info: GTIN 04546540199775; 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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