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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64313
Product Type Devices
Status Ongoing
Recalling Firm Stryker Spine
City Allendale
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. This device is not intended to sustain or support life. Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852. Class II Complaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use. 46 units US Z-0893-2013