Stryker Recalls Nine Femoral Nails Due to Potential Premature Breakage
Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical implant that could lead to device failure (premature breakage). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Stryker GmbH is recalling nine units of the Femoral Nail, A/R T2 Femur 12x360 mm (Product Number 18251236S). The recall was initiated after the manufacturer discovered that potentially out-of-specification products may have left the factory.
The specific defect involves non-conforming cannulation of the nails. This issue may result in reduced component strength and potentially lead to premature nail breakage. The affected products are identified by GTIN 04546540199775 and Lot code K081650.
The products were distributed to the following US states: Alabama, Colorado, Florida, Kentucky, North Carolina, Tennessee, Utah, and Washington. The source text does not specify the exact number of patients affected or report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
- Manufacturer
- Stryker GmbH
- Affected units
- 9
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 04546540199775
- Lot code: K081650
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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