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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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Event Detail

Event ID 62415
Product Type Devices
Status Ongoing
Recalling Firm Stryker Spine
City Allendale
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker Reliance AL Implant Blocker (Various sizes) Manufactured by: Stryker Spine SAS Z1 Marticot-33610-Cestas-France +33 ()) http://www.stryker.com Distributed in the USA by: STryker Spine 2 Pearl Court Allendale NJ 07401-1677 USA +1-201-760-8000 The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position. Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510 Class II Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. 109 Lots Z-2176-2012