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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 Recall
NexPosure Portal System
see related information
Date Posted April 01, 2013
Recall Status1 Open
Recall Number Z-1045-2013
Recall Event ID 64569
Premarket Notification
510(K) Numbers
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, Indiana 46580-2746
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
DESIGN: Packaging 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 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 = HRX and Original Applicant = ENDIUS, INC.
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