Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cerv…

Recall date

May 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2231-2020

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

US nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.