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U.S. Department of Health and Human Services

Class 2 Device Recall Slotted Femoral Head Provisional

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  Class 2 Device Recall Slotted Femoral Head Provisional see related information
Date Initiated by Firm April 01, 2011
Date Posted September 28, 2012
Recall Status1 Terminated 3 on May 16, 2014
Recall Number Z-2484-2012
Recall Event ID 62110
Product Classification Template - Product Code HWT
Product 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36
00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36
00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36
00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36
00780304005 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.
Code Information All lots including lot 78939000 (1/7/2002) 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 all lots, all sizes
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
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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