Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach of the sterile barrier for an implantable medical device, which poses a risk of infection or harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 147,838 units of T2 K-Wire 1.8 x 310 mm, Sterile. These medical devices are intended for the temporary stabilization of bone segments or fragments. The recall covers all lots distributed before November 10, 2015, with a non-expired 5-year shelf life, under catalog number 0152-0218S.
The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. This defect could potentially compromise the sterile barrier of the device. The affected 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 product. Patients who have already received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Stryker, T2 K-Wire 1.8 x 310 mm, Sterile 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 0152-0218S
- 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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