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 properly, 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (inadequate locking) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,235 units of Vital MIS Spinal Fixation system implants, specifically the CANN POLY EXT TAB 4.5X45MM (Item Number 810M4545). 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 was initiated 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 affected products 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 C20B0011, SBM108402, and SBM118984.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - 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)00887868324215
- Lot Numbers: C20B0011 SBM108402 SBM118984
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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