FDAFDA · Food and drugs·Recall number Z-0893-2013
Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
Published March 6, 2013 · Recall initiated: December 27, 2012
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
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Spine
- Distributor
- Nationwide Distribution including the states of AL, AZ, CA, CO, FL, GA, IA, IL,IN, KS, LA, MA, MD, MI, MO, MN, NC, NY. OH, OK, OR, PA, TN, TX, UT and WI.
- Lot
- Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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