Enforcement Report - Week of October 10, 2012
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Product Detail
| Product Description | 12/14 Neck Taper 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 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-2477-2012 |
| Classification | Class II |
| Code Info | All lots distributed from lot 69998600 (2/20/1996) to present |
| Product Distributed Qty | 231,641 |
| Reason For Recall | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada. |
Event Detail
| Event Id | 62110 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Zimmer, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-04-01 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. |
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