Stryker Recalls Femoral Nails Due to Potential Premature Breakage
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to 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 is classified as FDA Class II and involves a structural defect (premature breakage) in a load-bearing orthopedic implant, which aligns with the rubric criteria for 'Severe' severity involving significant injury potential or structural defects.
Plain-English summary
Stryker GmbH is recalling specific femoral nails (Product Number 18281236S) because the manufacturer discovered that potentially out-of-specification products may have left the factory. The recall involves the R1500 T2 Femur 12x360 mm model.
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 specific lot code is K076A7C and the GTIN is 04546540200686.
Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the return or replacement of these devices. No specific instructions for consumers are provided in the source text, but the affected devices are medical implants intended for professional use.
The recalled product
- Product
- Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
- 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: 04546540200686
- Lot code: K076A7C
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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