Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty. |
|---|---|
| Recall Number | Z-0399-2013 |
| Classification | Class II |
| Code Info | All lots distributed from lot 69998600 (2/20/1996) to present |
| Product Distributed Qty | 56,516 all lots, all sizes |
| Reason For Recall | Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed. |
Event Detail
| Event Id | 63066 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Zimmer, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-10-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. |
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