Zimmer Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2215-2020)
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 5.5X40MM, Item Number 810M5540 - 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)00887868324437; Lot Numbers: C19G0006 C19H0009 C19I0006 C19J0008 C19K0006 C19L0017 SBM108404 SBM118986 SBM121778
US nationwide distribution.
Voluntary: Firm initiated