Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Femoral Nail, RIGHT T2 GTN 14x460 mm (Product Number 18511446S) because some units may have left the factory with out-of-specification cannulation. This manufacturing defect may 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 recalled lot can be identified by GTIN 07613252129295 and lot code K0748D3.
Consumers with questions about whether they have received an affected product should contact their healthcare provider or Stryker GmbH. The recall notice does not specify a remedy or instructions for what affected consumers should do.
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: 07613252129295; Lot code: K0748D3
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.