# FDA recall Z-0021-2022

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

## Product

OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following:      a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX;      b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX;     c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX;      d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX;      e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX;      f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX;      g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX;        Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890.      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-0021-2022
- **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-0021-2022

## Citation

> AI Analytics. FDA recall Z-0021-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0021-2022. Source: US FDA. Licensed CC0.

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