Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Ankle Arthrodesis Nails (right T2 Ankle, 11x300mm, Product Number 18191130S, Lot code K081639) that were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The company 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 recall affects nails with GTIN 04546540673428 and Lot code K081639. The source document does not specify a remedy or recommended action for consumers who may have received affected products.
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: 04546540673428; Lot code: K081639
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.