Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 c...
FDA Recall #Z-0893-2013 — Class II — December 27, 2012
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.
Recalling Firm
Stryker Spine — Allendale, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated