| Class 2 Device Recall Neck Taper | |
Date Initiated by Firm | April 01, 2011 |
Date Posted | September 28, 2012 |
Recall Status1 |
Terminated 3 on May 16, 2014 |
Recall Number | Z-2477-2012 |
Recall Event ID |
62110 |
Product Classification |
Template - Product Code HWT
|
Product | 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
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. |
Code Information |
All lots distributed from lot 69998600 (2/20/1996) to present |
Recalling Firm/ Manufacturer |
Zimmer, Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | Brian Bishop 574-372-4753 |
Manufacturer 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. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp |
FDA Determined Cause 2 | Device Design |
Action | Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580.
For questions regarding this recall call 574-372-4753. |
Quantity in Commerce | 231,641 |
Distribution | Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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