—#116502

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.

FDA product code: HRX — Arthroscope
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K053267, K061345
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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

Timeline

Recall initiated: 2013-02-08
Posted by FDA: 2013-04-01
Terminated: 2014-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116502. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.