Data Foundry

Medical device recalls 2013

Zimmer NexPosure — Class II medical device recall Z-1045-2013

Terminated recall by Zimmer, Inc., reported 2013-04-10, distributed nationwide. Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner

Recall numberZ-1045-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2013-02-08
Classified2013-04-01
Reported by FDA2013-04-10
Terminated2014-12-09
DistributedNationwide (US)
Quantity58
Reason classessterility
Lot numbers61225572, 61267745, 61267750, 61267753, 61267756, 61267759, 61267760, 61267761, 61657007, 61657015, 61657016, 61657017, 61657018, 61657019, 61657031, 61664689, 61801814, 61873348, 61895685
Model numbersN182450-055, N182450-065, N182450-075, N182450-085, N1830L50-060, N1830L50-070, N1830L50-080, N1830L50-090, N1830L50-100, N1830L80-060, N1830L80-070, N1830L80-080, N1830L80-090, N1830L80-100, N1830R50-060, N1830R50-070, N1830R50-080, N1830R50-090, N1830R50-100, N1830R80-060, N1830R80-100

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 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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1045-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.