OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: ...
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.
Components:
Recall Date: Aug 30, 2021
Mfg:
Exactech, Inc.
Mfg Country:
United States
Recall ID: 88570
Product ID: 189260
Enforcement Date: Oct 13, 2021
Last Published: Apr 4, 2022
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Emert Number: Z-0021-2022
Emert Status: Updated