Zimmer Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2224-2020)
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 6.5X40MM, Item Number 810M6540 - 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)00887868324857; Lot Numbers: C19H0014 C19I0015 C19J0013 C19K0011 C19L0012 C19L0015 C19L0016 SBM108409 SBM118991 SBM122159
US nationwide distribution.
Voluntary: Firm initiated