Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.
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, which is generally associated with a temporary or medically reversible adverse health consequence. The hazard is a potential packaging defect (decreased seal integrity) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 147,838 units of the T2 Guidewire, Smooth-Tipped, 2.2 x 800mm. The product is 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 1806-0093S.
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 sterility of the medical device. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected guidewires and contact Stryker Howmedica Osteonics Corp. for instructions on return or replacement. Patients who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm 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 1806-0093S
- 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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