Stryker Recalls Left GAMMA3 Nails Marked as Right
Stryker Howmedica Osteonics is recalling five units of the GAMMA3 System Long Nail Kit, Left, because they are incorrectly marked as right nails.
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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a labeling error (mis-labeling) rather than a high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling five units of the GAMMA3 System Long Nail Kit, R2.0, Ti, Left. The affected devices are single-use intramedullary nails intended for the temporary fixation, correction, and stabilization of the femur. The recall is due to a labeling error where the left-sided nails are marked as right-sided nails.
The affected units are identified by Catalog Numbers 33250400S and 33250360S. These devices were distributed in the United States, specifically in the states of Illinois, Kentucky, and Tennessee. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and facilities that have received these specific catalog numbers should stop using the affected devices and contact Stryker Howmedica Osteonics for further instructions.
The recalled product
- Product
- GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 5
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- 33250400S Catalog Number 33250360S
Distribution
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