Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM Recalled by Zimmer Biomet, Inc. Due to There are reports of inadequate locking of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet, Inc. directly.
Affected Products
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 indicated for skeletally mature patients and for adolescence patients.
Quantity: 3235 total
Why Was This Recalled?
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report