FDAFDA · Food and drugs·Recall number Z-0877-2016
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Published March 2, 2016 · Recall initiated: January 21, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- US Nationwide Distribution
- Lot
- Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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