Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling 12 units of Tibial Nail, Standard T2 Tibia 12x315 mm (Product Number 18221231S) with lot code K074846. The manufacturer discovered that some products may have left the factory with out-of-specification cannulation, which could result in reduced component strength and potentially premature nail breakage. The affected products were distributed to Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington.
The recall record 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. Quantity: 12 Lot/code info: GTIN 04546540197771; Lot code: K074846
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.