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U.S. Department of Health and Human Services

Class 2 Device Recall NexPosure Portal System

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  Class 2 Device Recall NexPosure Portal System see related information
Date Initiated by Firm February 08, 2013
Date Posting Updated April 01, 2013
Recall Status1 Terminated 3 on December 09, 2014
Recall Number Z-1045-2013
Recall Event ID 64569
510(K)Number K053267  K061345  
Product Classification Arthroscope - Product Code HRX
Product Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060, N1830L50-100, N1830L50-090, N1830L50-080, N1830L50-070, N1830L50-060, ¿ N182450-085, N182450-075, N182450-065, N182450-055, N182450-045.¿ Retractor access system that allows placement of posterior spinal fixation implants.
Code Information Lot Number, 61225572 , 61664689 , 61664689 , 61657007 , 61657015 , 61657015 , 61267745 , 61267745 , 61267750 , 61267750 , 61267753 , 61267753 , 61657016 , 61657016 , 61801814 , 61895685 , 61657017 , 61657018 , 61657018 , 61267756 , 61267756 , 61267759 , 61267759 , 61267760 , 61267760 , 61267761 , 61267761 , 61267761 , 61873348 , 61657019 , 61657019 , 61657031 , 61657031 .
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall
Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may o
FDA Determined
Cause 2
Package design/selection
Action Consignees were sent on 2/8/13 a Zimmer Spine "Urgent Medical Device Recall" letter dated February 08, 2013. The letter was sent to Surgeons and Facilities using the NexPosure MIS Access System. The letter described the product involved in the recall and the problem. Advised consignees to discontinue the use of the product and to contact their sales representative for removal. A consignee letter dated February 8, 2013 was also sent to Distributors, Sales Representatives, and Distribution Operation Managers Distributing the NexPosure¿ MIS Access System. The letter contained instructions if they had the affected product or not and the steps to follow.
Quantity in Commerce 58
Distribution Nationwide Distribution including the states of AZ, CO, DE, FL, ID, LMA, MI, NH, NJ, NM, PA, RI, TX, and VA.
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 = HRX and Original Applicant = ENDIUS, INC.
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