# FDA recall Z-0022-2022

> **Exactech, Inc.** · Class II · device recall initiated 2021-08-30.

## Product

OPTETRAK Comprehensive Knee System custom devices labeled as the following:     a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX);     b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX);     c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX).       NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

## Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA  .

## Key facts

- **Recall number:** Z-0022-2022
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-30
- **Report date:** 2021-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2022

## Citation

> AI Analytics. FDA recall Z-0022-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0022-2022. Source: US FDA. Licensed CC0.

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