Stryker T2 K-Wire Recall Due to Potential Pouch 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, and the hazard is a potential packaging defect (decreased seal integrity) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Stryker T2 K-Wires, 3.2x400mm, CoCr, Recon. These medical devices are intended for the temporary stabilization of bone segments or fragments. The recall involves 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. This potential defect could affect the sterility or protection of the device. The affected products are identified by catalog number 1806-3031S. 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 check their inventory for the specific catalog number and distribution dates mentioned above. If the product is found, it should be removed from use and returned to Stryker Howmedica Osteonics Corp. according to their instructions.
The recalled product
- Product
- Stryker, T2 K-Wire, 3.2x400mm, CoCr, 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 1806-3031S
- 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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