Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling seven Femoral Nail A/R R1500 T2 Femur devices (10x320 mm, Product Number 18281032S, Lot code K08327D) that may not meet manufacturing specifications. The defect involves improper cannulation of the nails, which could reduce their structural strength and lead to premature breakage. These products were distributed to medical facilities in Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.
Consumers or healthcare facilities that received this product should contact the manufacturer, as the recall documentation does not specify a particular remedy or course of action.
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: 7 Lot/code info: GTIN 04546540200402; Lot code: K08327D
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.