# FDA recall Z-2227-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2020-05-05.

## Product

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - 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

US nationwide distribution.

## Key facts

- **Recall number:** Z-2227-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-05
- **Report date:** 2020-06-10
- **Termination date:** 2022-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2020

## Citation

> AI Analytics. FDA recall Z-2227-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2227-2020. Source: US FDA. Licensed CC0.

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