Zimmer Biomet Recalls Vital MIS Spinal Fixation System Implants
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws.
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 is classified as FDA Class II. The hazard involves a structural failure of a spinal implant (screw backing out), which poses a risk of harm, but the source text does not explicitly report hospitalizations or deaths, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling Vital MIS Spinal Fixation system implants, specifically the CANN POLY EXT TAB 6.5X50MM (Item Number 810M6550). 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 indicated that the closure top backed out of the screw post-operatively.
A total of 3,235 units were distributed nationwide in the United States. Affected lot numbers include C19H0017, C19I0018, C19J0016, C19L0007, C19L0014, C20A0001, SBM108411, SBM118993, SBM122201, and SBM122311. The UDI for the product is (01)00887868324871. Patients who have received these implants should contact their healthcare provider for evaluation.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - 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.
- 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)00887868324871
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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