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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0893-2013
Classification Class II
Code Info Catalog Number: 48231326. Lot Number: 10G637; 10G638 and 10E852.
Product Distributed Qty 46 units US
Reason For Recall Complaints have been reported indicating that surgeons have experienced unthreading of the screwdrivers outer shafts during use.

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 Letter
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.