Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Ankle Arthrodesis Nails (right T2 Ankle, 10x300mm, Product Number 18191030S) with lot code K078C7E because some products may not meet manufacturing specifications. The defect involves improper cannulation of the nails, which could reduce their strength and potentially cause them to break prematurely.
The affected products were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The recall does not specify what actions affected consumers should take.
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: 04546540673398; Lot code: K078C7E
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.