Recall Z-0893-2013 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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.
| Date | Feb 28, 2013 (initiated Dec 27, 2012) |
| Status | Terminated |
| Reason | Surgeons have experienced unthreading of the screwdrivers outer shafts during use. |
| Root cause | Device Design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.