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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Segmental Systems

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  Class 2 Device Recall Zimmer Segmental Systems see related information
Date Initiated by Firm December 19, 2013
Date Posted January 17, 2014
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-0784-2014
Recall Event ID 66846
510(K)Number K070978  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product Zimmer Segmental Systems; Polyethylene Inserts, Size C.

Knee replacement.
Code Information Part numbers 00-5850-013-95
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
FDA Determined
Cause 2		 Device Design
Action Depth of recall " Notifications were sent to customers, surgeons and risk managers, which use the affected product. Distributors were also informed of the notifications sent to surgeons and risk managers. The customers were identified by performing an invoice search and distribution history for the Polyethylene Inserts (00-5850-012-95 and 00-5850-013-95) since product launch. Recall Communication " All distributors were notified via electronic mail. Distributors that have received affected inventory were also notified via courier. Hospital risk managers and surgeons were also notified via courier. On 12/19/13, hospital risk managers and surgeons were provided with a notification identifying the issue and their responsibilities. These responsibilities include ensuring the affected personnel are aware of the contents of the notification. On 12/19/13, Distributors were sent a notification identifying the issue and to provide a copy of the notification sent to surgeons and risk managers. The distributors will also be instructed as needed to assist with identifying a comprehensive list of surgeons. " Communications outside of the United States will occur approximately two weeks after the United States communications. Effectiveness Checks Zimmer will conduct effectiveness checks in the following way: "Surgeons/Hospitals o100% of the FedEx notifications will be accounted for. oSecond and third notification attempts will be made. oFailed delivery attempts following the third attempt will result in the account being deemed as nonresponsive.
Quantity in Commerce 5305 distribution events
Distribution Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
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.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = ZIMMER, INC.
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