FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.
What this means for you
Illness, injury, or structural failure has been reported. 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, and the source text describes a structural defect (inadequate locking) in a spinal fixation device, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Zimmer Biomet, Inc.'s Vital MIS Spinal Fixation system implants, specifically the CANN BL POLY EXT 8.5X45MM (Item Number 811M8545). The recall involves 3,235 units distributed nationwide in the United States. The affected products 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 were received indicating that the closure top backed out of the screw post-operatively. This defect poses a risk of device failure or malfunction during or after the surgical procedure.
Healthcare providers and patients who have received these specific implants should contact Zimmer Biomet, Inc. for further instructions. The FDA advises that these devices should not be used until the recall is resolved. Consumers should verify the lot number (SBM108419) and UDI (01)00887868326127) to determine if their specific implant is affected.
The recalled product
- Product
- Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
- 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)00887868326127
- Lot Numbers: SBM108419
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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