FDA Device recall Z-2220-2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixatio…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixatio… by Zimmer Biomet, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2220-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-05 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - 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
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.
Identifiers
| code_info | UDI: (01)00887868324864; Lot Numbers: C19G0005 C19H0015 C19I0014 C19J0014 C19K0012 C19L0006 C20A0007 C20A0014 C…UDI: (01)00887868324864; Lot Numbers: C19G0005 C19H0015 C19I0014 C19J0014 C19K0012 C19L0006 C20A0007 C20A0014 C20A0015 C20B0007 C20B0008 C20B0009 SBM108410 SBM109981 SBM109982 SBM109983 SBM118992 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2220-2020%22
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