Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Femoral Nail A/R model R1500 T2 Femur 12x300 mm (Product Number 18281230S, GTIN: 04546540200655) due to a manufacturing defect. The manufacturer discovered that some products may have left the factory with out-of-specification cannulation, which could reduce component strength and lead to premature nail breakage. The affected product has Lot code K07AFF5 and was distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.
The source does not specify what remedy is available for affected consumers.
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: 04546540200655; Lot code: K07AFF5
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.