Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and clo
FDA device recall Z-0893-2013 · posted 2013-02-28 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 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.
- Date initiated
- 2012-12-27
- Date posted
- 2013-02-28
- Date terminated
- 2015-09-30
- Location
- Allendale, NJ
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