Recall Z-0893-2013
Stryker Spine · initiated December 27, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
Reason for recall
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
FDA-determined cause: Device Design
Action taken
Stryker Spine sent a "Urgent Medical Device Removal" letter dated January 14 2013, via FedEx overnight to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine your inventory and hospital inventory locations to identify your product. Please fax a copy of the Customer Response form to (855) 632-9049 to Regulatory Compliance. For further questions please call (201) 760-8298.
Details
- Recall number
- Z-0893-2013
- Initiated
- December 27, 2012
- Posted by FDA
- February 28, 2013
- Terminated
- September 30, 2015
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- 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.
- Recalling firm
- Stryker Spine, Allendale, NJ