Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6 — Class II medical device recall Z-2220-2020
Terminated recall by Zimmer Biomet, Inc., reported 2020-06-10, distributed nationwide. There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure
| Recall number | Z-2220-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-05-05 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2022-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 3,235 total |
| UPC / GTIN / UDI-DI | 00887868324864 |
| Lot numbers | C19G0005, C19H0015, C19I0014, C19J0014, C19K0012, C19L0006, C20A0007, C20A0014, C20A0015, C20B0007, C20B0008, C20B0009, SBM108410, SBM109981, SBM109982, SBM109983, SBM118992 |
| Model numbers | 810M6545 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2220-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.