Agency classClass IIOur severity:Severe FDA (Devices)·Z-2233-2020·Announced 2020-06-10

Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

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 structural defect in a spinal implant where the device failed post-operatively, meeting the criteria for a Severe rating due to significant injury risk.

Plain-English summary

Zimmer Biomet, Inc. is recalling Vital MIS Spinal Fixation system implants, specifically the VITAL MIS TAB BREAKER (Item Number 850M0055). These are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation in skeletally mature and adolescent patients.

The recall is being issued due to reports of inadequate locking of the extended tab screws. Complaints have been received indicating that the closure top backed out of the screw post-operatively. A total of 3,235 units were distributed nationwide in the United States.

Healthcare providers and patients who have received these implants should contact Zimmer Biomet for further instructions on how to proceed. The recall number for this action is Z-2233-2020.

The recalled product

Product: Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Spinal Fixation
Hazard: structural-failure
device-malfunction
Affected units: 3,235

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI: (01)00887868310140
Lot Numbers: 136158 136158 143757 311626

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 25 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · structural failure