Stryker Recalls Specific Femoral Nail Due to Potential Breakage Risk
Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.
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 nail breakage) in an orthopedic implant, which aligns with the rubric criteria for 'structural vehicle defect' or significant injury risk in medical devices.
Plain-English summary
Stryker GmbH is recalling one unit of the Femoral Nail, A/R T2 Femur 15x240 mm (Product Number 18251524S). The recall is being conducted because the manufacturer discovered that potentially out-of-specification products may have left the factory.
The specific defect involves non-conforming cannulation of the nails, which may result in reduced component strength and potentially premature nail breakage. The affected product is identified by GTIN 04546540200105 and Lot code K078C70.
The product was distributed to the following US states: AL, CO, FL, KY, NC, TN, UT, and WA. Healthcare providers and patients should contact Stryker GmbH for further instructions regarding the recall.
The recalled product
- Product
- Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
- Manufacturer
- Stryker GmbH
- Affected units
- 1
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 04546540200105
- Lot code: K078C70
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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