# FDA recall Z-2868-2020

> **Globus Medical, Inc.** · Class II · device recall initiated 2020-07-22.

## Product

ALTERA Spacer  ALTERA Spacer, 10x36, 12-16mm, 8¿

## Reason for recall

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-2868-2020
- **Recalling firm:** Globus Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-22
- **Report date:** 2020-09-02
- **Termination date:** 2021-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Audubon, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2868-2020

## Citation

> AI Analytics. FDA recall Z-2868-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2868-2020. Source: US FDA. Licensed CC0.

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