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U.S. Department of Health and Human Services

Class 2 Device Recall ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION

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 Class 2 Recall
ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION
see related information
Date Posted December 27, 2013
Recall Status1 Open
Recall Number Z-0589-2014
Recall Event ID 66499
Premarket Notification
510(K) Number
K082078 
Product Classification Guide, Surgical, Instrument - Product Code FZX
Product ITST THREADED GUIDE PIN
Code Information Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.
Quantity in Commerce 42, 065 units total
Distribution Worldwide Distribution.
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.
510(K) Database 510(K)s with Product Code = FZX and Original Applicant = ZIMMER, INC.
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