Recall Z-0022-2022— Exactech, Inc.

Name: FDA recall Z-0022-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-30

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2021-08-30. FDA's recall record names no specific 510(k) clearance for this event. 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: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-08-30
Firm location: Gainesville, FL, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.