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FDAMay 5, 2020device

Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - 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 mat...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

UPCs

00887868310140

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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