Recall Z-0893-2013— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2012-12-27, terminated 2015-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Surgeons have experienced unthreading of the screwdrivers outer shafts during use..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-27
- Terminated
- 2015-09-30
- Firm location
- Allendale, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.