The Recall Desk
ModerateFDA (Devices)·Z-0876-2016·Announced 2016-03-02

Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires 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 does not report any illnesses, injuries, or hospitalizations. The hazard is a potential packaging defect (decreased seal integrity) without confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Stryker Howmedica Osteonics Corp. is recalling the Stryker T2 Guidewire, Ball-Tipped, 2.5x800 mm. The product is intended for the temporary stabilization of bone segments or fragments. A total of 147,838 units are affected by this recall.

The recall was initiated after a review of the packaging determined that the seal integrity of the pouch may be decreased. The affected units are identified by Catalog number 1806-0083S and include all lots distributed before November 10, 2015, with 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 guidewires and contact Stryker Howmedica Osteonics Corp. for further instructions on the recall.

The recalled product

Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
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 1806-0083S
  • 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.

See all 18 products in this recall →