Stryker Recalls Mislabelled Femoral and Tibial Nails
Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly identifies the issue as incorrect labeling and distribution without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific units of the T2 Femoral Nailing System, including the Femoral Nail, A/R T2 Femur 011x280 mm, and a Tibial Nail. The recall was initiated because the company discovered that these medical devices were incorrectly labeled and distributed to the field.
The affected products are identified by Catalog number 18251032S and Lot Code K288335. The distribution was limited to the state of California, with a total quantity of 1 unit in total. The T2 Femoral Nailing System is designed for the repair of various femoral fractures, including open and closed fractures, pseudoarthrosis, and pathologic fractures.
Healthcare providers and patients who have received these specific devices should contact Stryker Howmedica Osteonics Corp. for further instructions on how to handle the recalled items. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and corr
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- 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 (1)
- Catalog number 18251032S and Lot Code K288335
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Stryker Howmedica Osteonics Corp. 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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