Exactech, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0027-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Product Classification:

Class II

Date Initiated: August 30, 2021

Date Posted: October 13, 2021

Recall Number: Z-0027-2022

Event ID: 88570

Reason for Recall:

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

Status: Ongoing

Product Quantity: 12 devices

Code Information:

Item Number (Device Identifier; Serial number(s)): 256-12-02 (No Device Identifier; 1208624, 1208625, 1208626, 1208627); 256-12-03 (10885862066633; 1208774, 1446326); 256-13-02 (No Device Identifier; 1208710, 1208715); 256-13-03 (No Device Identifier; 1208859, 1208863); 256-13-04 (No Device Identifier; 1209010, 1209013)

Distribution Pattern:

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 .

Voluntary or Mandated:

Voluntary: Firm initiated