Stryker Recalls Mislabelled T2 Supracondylar Nail System
Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.
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 2/5 (Moderate).
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, and the source text describes a labeling error without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System, specifically the Supracondylar Nail T2 SCN 09x300 mm. The product is intended to provide strong and stable internal fixation of the distal femur for various fractures and orthopedic conditions.
The recall was initiated because Stryker discovered that a Tibial Nail and a femoral Nail were incorrectly labeled and distributed to the field. The specific unit involved is identified by Catalog number 18220930S and Lot Code K836729.
The affected product was distributed in the United States to the state of California. The source text does not specify the number of patients affected or report any injuries or illnesses associated with the mislabeling.
The recalled product
- Product
- Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3)…
- 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 18220930S and Lot Code K836729
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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