Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
Check against the official notice below — it lists the full affected range.
Stryker GmbH has recalled Femoral Nail A/R, R1500 T2 Femur 12x380 mm (Product Number 18281238S) because some products may have left the factory with out-of-specification cannulation. This manufacturing defect could reduce the strength of the nails and potentially lead to premature breakage. The affected products were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.
The recalled products can be identified by GTIN 04546540200693 and lot code K08327F. The source document does not specify what remedy consumers should pursue.
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: 04546540200693; Lot code: K08327F
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.