FDA-Device2013-03-06Class II
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.
Stryker Spine
Hazard
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Sold states
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.
Affected count
46 units US
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0893-2013Don't want to check this manually?
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