Agency classClass IIOur severity:Severe FDA (Devices)·Z-1045-2013·Announced 2013-04-10

Zimmer NexPosure Retractor Portals Recalled for Sterility Risk

Zimmer, Inc. is recalling 58 NexPosure retractor portals due to a potential breach in the sterile inner pouch, which could lead to product contamination and patient infection.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient infection due to loss of sterility, which meets the criteria for a Severe rating.

Plain-English summary

Zimmer, Inc. is recalling 58 units of the NexPosure retractor portals, part of the NexPosure MIS Access System. These medical devices are used to allow the placement of posterior spinal fixation implants. The recall is due to a possibility that the sterile inner pouch may be compromised. The product is packaged in two pouches, with a sterile inner pouch within an external pouch.

If the inner pouch is breached, there is an increased risk of contamination and loss of product sterility if proper aseptic technique is not followed when transferring the inner package into the sterile field. This condition may lead to patient infection. The recall is classified as FDA Class II.

The affected units were distributed nationwide, including in Arizona, Colorado, Delaware, Florida, Idaho, Louisiana, Michigan, New Hampshire, New Jersey, New Mexico, Pennsylvania, Rhode Island, Texas, and Virginia. Healthcare facilities should stop using the affected retractor portals and contact Zimmer, Inc. for further instructions.

The recalled product

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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Surgical Instrument
Hazard: contamination
infection
Affected units: 58

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Same manufacturer · Zimmer, Inc.

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