Device product
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.
Z-0893-2013
Product summary
- Firm
- Stryker Spine
- Event
- Event 64313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 units US
- Official record key
device-enforcement:Z-0893-2013
Official wording
Reason: Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Code information: Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.