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.
What this means for you
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 mechanical failure (inadequate locking) in a spinal implant, which poses a risk of harm, but the source text does not report specific injuries, hospitalizations, or fatalities, fitting the criteria for a high-risk product where injury has not yet been explicitly reported in the provided text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,235 units of Vital MIS Spinal Fixation system implants, specifically the CANN POLY EXT TAB 5.5X35MM (Item Number 810M5535). These non-cervical spinal fixation devices are 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 were distributed nationwide in the United States.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the replacement or removal of these devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
- 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)00887868324420
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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