Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a potential decrease in packaging seal integrity, which is a precautionary measure to ensure sterility, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 147,838 units of T2 K-Wires with washers (7.8 x 3 x 285mm). These medical devices are intended for the temporary stabilization of bone segments or fragments. 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 1806-0051S. The recall includes 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.
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. Patients who have already had these devices implanted should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm 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 1806-0051S
- 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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