|Date Initiated by Firm
||October 10, 2010
|Date Posting Updated
||November 19, 2012
||Terminated 3 on April 30, 2014
|Recall Event ID
||Template - Product Code HWT
||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.
||All lots distributed from lot 69998600 (2/20/1996) to present
| Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
|For Additional Information Contact
|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
||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
||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.