Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Femoral Nail A/R, R1500 T2 Femur 12x360 mm (Product Number 18281236S, Lot code K076A7C) because some units may have left the factory out of specification. The defect involves non-conforming cannulation of the nails, which could reduce component strength and potentially cause premature nail breakage. The affected products were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.
According to the recall record, no remedy information is specified for consumers who may have received this product.
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. Lot/code info: GTIN: 04546540200686; Lot code: K076A7C
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.