FDA-Device2020-06-10Class II
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - 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.
Zimmer Biomet, Inc.
Hazard
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.
Sold states
US nationwide distribution.
Affected count
3235 total
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2231-2020Don't want to check this manually?
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