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Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cerv
Recalled June 10, 2020 · FDA recall Z-2234-2020 · Zimmer Biomet
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. · FDA Class II
Units
3235 total
Sold at
US nationwide distribution.
Description
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.
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - 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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →