Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling 2 units of Femoral Nail, A/R T2 Femur 10x320 mm (Product Number 18251032S, Lot Code K081642) because the manufacturer discovered that potentially out-of-specification products may have left the factory. The defect involves non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage.
The affected products were distributed to eight US states: Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The source does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 2 Lot/code info: GTIN 04546540199492; Lot code: K081642
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.