# FDA recall Z-0629-2021

> **Biomet, Inc.** · Class II · device recall initiated 2020-11-25.

## Product

Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone

## Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Distribution

Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil,  CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

## Key facts

- **Recall number:** Z-0629-2021
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-25
- **Report date:** 2020-12-23
- **Termination date:** 2024-05-08

- **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-0629-2021

## Citation

> AI Analytics. FDA recall Z-0629-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0629-2021. Source: US FDA. Licensed CC0.

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