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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide Distribution.