Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because 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 source text describes a structural defect in a spinal implant where the closure top backs out post-operatively. This constitutes a significant injury risk and falls under the 'Severe' criteria for structural defects or significant injury reports in medical devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling Vital MIS Spinal Fixation system implants, specifically the CANN BL POLY EXT 8.5X55MM (Item Number 811M8555). 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 due to reports of inadequate locking of the extended tab screws. Complaints indicate that the closure top backed out of the screw post-operatively. The recall involves 3,235 units distributed nationwide in the United States. The affected lot numbers are SBM109985 and SBM109986, with UDI (01)00887868326141.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - 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
- 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)00887868326141
- Lot Numbers: SBM109985 SBM109986
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.
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