Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a potential packaging defect (decreased seal integrity) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Stryker Gamma K-Wires, 3.2x450 mm, UNS-Thread. These medical devices are intended for the temporary stabilization of bone segments or fragments. The recall affects 147,838 units distributed nationwide in the United States.
The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. The affected products are identified by catalog number 1210-6451S. All lots distributed before November 10, 2015, with a non-expired 5-year shelf life, are included in this recall.
Healthcare providers and facilities should stop using the affected K-Wires and contact Stryker Howmedica Osteonics Corp. for instructions on how to return or dispose of the products.
The recalled product
- Product
- Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 147,838
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)
- Catalog number 1210-6451S
- All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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