FDA Device recall Z-1045-2013
Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-…
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-… by Zimmer, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1045-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-08 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | Lot Number 61225572 61664689 61664689 61657007 61657015 61657015…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1045-2013%22
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