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U.S. Department of Health and Human Services

Class 2 Device Recall VerSys Hip System Provisional Femoral Head 12/14 Neck Taper

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  Class 2 Device Recall VerSys Hip System Provisional Femoral Head 12/14 Neck Taper see related information
Date Initiated by Firm October 10, 2010
Date Posted November 19, 2012
Recall Status1 Terminated 3 on April 30, 2014
Recall Number Z-0394-2013
Recall Event ID 63066
Product Classification Template - Product Code HWT
Product 00789504001 VerSys Femoral Head Provisional 40mm -3.5
00789504002 VerSys Femoral Head Provisional 40mm +0
00789504003 VerSys Femoral Head Provisional 40mm +3.5
00789504004 VerSys Femoral Head Provisional 40mm +7
00789504005 VerSys Femoral Head Provisional 40mm +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
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 Dawn Kindle
574-372-4807
Manufacturer Reason
for Recall		 Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to 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. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
FDA Determined
Cause 2		 Device Design
Action The firm, Zimmer, sent notification by email to consignees beginning October 10, 2012 with a follow-up letter titled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete a spreadsheet of current users and contact information and immediately provide this information via email to: CorporateQuality.Postmarket@zimmer.com, and review and become familiar with the content and recommendations of the attached letter sent to the customers. For questions call 1-877-946-2761.
Quantity in Commerce 128,946 all lots, all sizes
Distribution Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
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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