medical Class II Updated 2021-10-13

Exactech, Inc. recalls ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-1

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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)
View official government recall

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