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. According to the rubric, an FDA Class II recall involving a structural defect in a medical implant that results in post-operative failure (backing out of the screw) falls under the 'Severe' category, as it represents a significant risk of injury or device failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,235 units of Vital MIS Spinal Fixation system implants, specifically the CANN BL POLY EXT 8.5X40MM (Item Number 811M8540). 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 conducted 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. The affected units are identified by UDI (01)00887868326110 and Lot Number SBM109984.
The affected products were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - 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)00887868326110
- Lot Numbers: SBM109984
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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