Zimmer Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2225-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - 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.
Class II
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.
UDI: (01)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160
US nationwide distribution.
Voluntary: Firm initiated