Z-2222-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- May 5, 2020
- Termination Date
- July 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3235 total
Product Description
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - 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.
Reason for Recall
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.
Distribution Pattern
US nationwide distribution.
Code Information
UDI: (01)00887868324888; Lot Numbers: C19I0001 C19I0010 C19J0020 C19L0003 C20A0018 SBM108412 SBM118994