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U.S. Department of Health and Human Services

Class 2 Device Recall XIA 3 Iliac Screwdriver, 3PCS

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 Class 2 Recall
XIA 3 Iliac Screwdriver, 3PCS
see related information
Date Posted February 28, 2013
Recall Status1 Open
Recall Number Z-0893-2013
Recall Event ID 64313
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
For Additional Information Contact Daniel Roberts
201-760-8298
Manufacturer Reason
for Recall
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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