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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

Product Description 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.
Recall Number Z-0656-2013
Classification Class II
Code Info Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
Product Distributed Qty 6021-2530- four units; 6021-3535-
Reason For Recall Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

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 Letter
Distribution Pattern Nationwide distribution, including the states of NY, NJ, CA and FL.