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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64306
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306 Class II Stryker® Orthopaedics has received reports from the field indicating handle fracture and subsequent disassociation of cam assembly subcomponents during use. 48 units Z-0919-2013