Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. |
|---|---|
| Recall Number | Z-0062-2013 |
| Classification | Class II |
| Code Info | Item 00-8114-001-10, lots 61947699 and 61952551 |
| Product Distributed Qty | 59 both lots |
| Reason For Recall | Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue. |
Event Detail
| Event Id | 63124 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Zimmer, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-13 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil. |
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