Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 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, 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 voluntary precautionary measures where harm has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 147,838 units of Stryker T2 K-Wire, 3.2x400mm, Recon. The product is intended for the temporary stabilization of bone segments or fragments. The recall involves catalog number 1806-3030S, specifically all lots distributed before November 10, 2015, that have a non-expired 5-year shelf life. The products were 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. This potential defect could affect the sterility or protection of the medical device.
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 product. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Stryker, T2 K-Wire, 3.2x400mm, Recon 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 1806-3030S
- 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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