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U.S. Department of Health and Human Services

Class 2 Device Recall MIS Slotted Femoral Head Provisional

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 Class 2 Recall
MIS Slotted Femoral Head Provisional
see related information
Date Posted November 19, 2012
Recall Status1 Terminated on April 30, 2014
Recall Number Z-0400-2013
Recall Event ID 63066
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 distributed from lot 69998600 (2/20/1996) to present
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Dawn Kindle
574-372-4807
Manufacturer Reason
for Recall
Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements 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. The observed rate of occurrence for this typ
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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 56,516 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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