Agency classClass IIOur severity:Severe FDA (Devices)·Z-2217-2020·Announced 2020-06-10

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

Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the closure top may back out of the screw post-operatively.

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 involves a structural defect in a spinal fixation device where the closure top backs out post-operatively, which constitutes a significant injury risk and aligns with the 'Severe' criteria for structural defects or significant injury reports.

Plain-English summary

Zimmer Biomet, Inc. is recalling 3,235 units of Vital MIS Spinal Fixation system implants, specifically the CANN POLY EXT TAB 5.5X50MM (Item Number 810M5550). These non-cervical spinal fixation devices are intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation in skeletally mature and adolescent patients.

The recall was initiated due to reports of inadequate locking of the extended tab screws. Complaints were received indicating that the closure top backed out of the screw post-operatively. The affected units were distributed nationwide in the United States.

Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The affected lot numbers are C19H0010, C19I0008, C19J0012, C19K0008, C20A0005, SBM108406, SBM118988, and SBM122122.

The recalled product

Product: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Spinal Fixation
Hazard: structural-defect
mechanical-failure
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 (1)

UDI: (01)00887868324451

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.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · structural defect