Recall Z-0020-2022— Exactech, Inc.

Name: FDA recall Z-0020-2022
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. It names one FDA 510(k) clearance: K040889. Product: OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-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

510(k) clearances named in this recall

1 on FDA's record

K040889 — EXACTECH OPTETRAK UNICONDYLAR KNEEExactech, Inc.·cleared 2004-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-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.