Agency classClass IIOur severity:Severe FDA (Devices)·Z-2229-2020·Announced 2020-06-10

FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants

Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

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 the source text describes a structural defect (inadequate locking) in a spinal fixation device, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Zimmer Biomet, Inc.'s Vital MIS Spinal Fixation system implants, specifically the CANN BL POLY EXT 8.5X45MM (Item Number 811M8545). The recall involves 3,235 units distributed nationwide in the United States. The affected products 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 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. This defect poses a risk of device failure or malfunction during or after the surgical procedure.

Healthcare providers and patients who have received these specific implants should contact Zimmer Biomet, Inc. for further instructions. The FDA advises that these devices should not be used until the recall is resolved. Consumers should verify the lot number (SBM108419) and UDI (01)00887868326127) to determine if their specific implant is affected.

The recalled product

Product: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - 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: device-failure
structural-defect
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)00887868326127
Lot Numbers: SBM108419

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 · device failure