medical Class II Updated 2020-06-10

Zimmer Biomet, Inc. recalls Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8

Recalled Product

Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - 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

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00887868326134; Lot Numbers: SBM108420
View official government recall

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