Date Initiated by Firm | October 10, 2010 |
Date Posted | November 19, 2012 |
Recall Status1 |
Terminated 3 on April 30, 2014 |
Recall Number | Z-0393-2013 |
Recall Event ID |
63066 |
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 | 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 |
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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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