Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN POLY EXT TAB
Recalled Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - 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.
Hazard / Issue
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.
Issued by
FDA
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