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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 61718
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 2012-10-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution, including the states of NY, NJ, CA and FL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint. Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US. Class II Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. 6021-2530- four units; 6021-3535- Z-0656-2013