Stryker Recalls Femoral Nails Due to Potential Premature Breakage
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical implant (premature breakage) which poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Stryker GmbH is recalling the Femoral Nail, LEFT T2 GTN 14x300 mm, Product Number 18501430S. The manufacturer identified that potentially out-of-specification products may have left the factory.
The recall is due to non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage. The products were distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA.
The affected products have GTIN 04546540647078 and Lot code K078C74. Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the recall.
The recalled product
- Product
- Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
- Manufacturer
- Stryker GmbH
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 04546540647078
- Lot code: K078C74
Distribution
Part of a larger recall action
This product is one of 16 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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