Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830

FDA device recall Z-1045-2013 · posted 2013-04-01 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

HRX

Quantity affected

58

Distribution

Nationwide Distribution including the states of AZ, CO, DE, FL, ID, LMA, MI, NH, NJ, NM, PA, RI, TX, and VA.

Date initiated

2013-02-08

Date posted

2013-04-01

Date terminated

2014-12-09

Location

Warsaw, IN

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