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

Stryker GmbH: Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S

Is my product affected?

Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S

  • UPC 04546540647320

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

What happened

Stryker GmbH has recalled Femoral Nail RIGHT T2 GTN 9x320 mm (Product Number 18510932S) with lot code K076A80 due to potentially out-of-specification products that may have left the factory. The nails may have non-conforming cannulation, which could result in reduced component strength and potentially premature nail breakage. The affected products were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.

The product is identified by GTIN 04546540647320 and lot code K076A80. The source document does not specify a remedy or instructions for affected 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: 04546540647320; Lot code: K076A80

Source

Official record: FDA (Device enforcement) ↗

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

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