Z-1045-2013Class II

Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers...

Name: Z-1045-2013 Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers...
Creator: Zimmer, Inc.
Published: 2013-02-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-02-08 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090, N1830R80-080, N1830R80-070... on 2013-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1045-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-08
Posted: 2013-04-01
Terminated: 2014-12-09
Recalling firm: Zimmer GmbH
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.
Product code: HRX Arthroscope
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
Root cause tag: packaging
FDA root cause: Package 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1045-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code HRX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)