Enforcement Report - Week of October 10, 2012
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Product Detail
| Product Description | 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper 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-2473-2012 |
| Classification | Class II |
| Code Info | All lots distributed from lot 69998600 (2/20/1996) to present |
| Product Distributed Qty | 231641 all sizes |
| Reason For Recall | Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. 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. Fourteen (14) of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. Provisional head dislodging may result from a number of combined factors, including patient BMI, patient soft tissue tension, incision size, and mating taper fit of the provisional. |
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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