Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
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 describes a potential packaging defect without reporting any specific injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or precautionary measures where harm has not been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Stryker Gamma3 K-Wires with Washers (13x3.2x500 mm). The recall involves 147,838 units distributed nationwide in the United States. The specific catalog number is 1320-0016S, and the recall covers all lots distributed before November 10, 2015, that have a non-expired 5-year shelf life.
The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. This product is intended for the temporary stabilization of bone segments or fragments. A compromised seal could potentially affect the sterile barrier of the device.
Healthcare providers and facilities should stop using the affected units and contact Stryker Howmedica Osteonics Corp. for further instructions or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm 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 1320-0016S
- 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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