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.
Reported: March 6, 2013 Initiated: December 27, 2012 #Z-0893-2013
Product Description
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.
Reason for Recall
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Details
- Recalling Firm
- Stryker Spine
- Units Affected
- 46 units US
- Distribution
- 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.
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Spine. Units affected: 46 units US.
Why was this product recalled? ▼
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0893-2013.
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