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. |
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