Z-2225-2020 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 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.
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)00887868325281; Lot Numbers: C19I0005 C19I0016 C19J0018 C19L0010 C20A0009 C20A0011 C20A0013 SBM108415 SBM118997 SBM120813 SBM122160