What Implants are Impacted by the 2022 Exactech Poly Recall?

Surgeons in the United States received an Exactech recall letter in February 2022 that detailed problems with certain knee and ankle implants packaged in “non-conforming” bags.

According to the letter, each of the recalled Exactech knee or ankle replacements contained a polyethylene plastic insert which was placed in a defective vacuum bag. These “non-conforming bags” did not contain another barrier layer of ethylene vinyl alcohol (EVOH), which provides critical oxygen resistance for the implant.

Consequently, the Exactech poly recall was issued because the ineffective bags may have allowed ...