The recall was initiated on August 31, 2021, and updated in 2022 after Exactech discovered that 80% of their polyethylene (plastic) inserts were improperly packaged in bags that may not have adequately prevented oxygen permeation.
The bags used were oxygen-resistant vacuum bags, but they lacked the required secondary protective mechanism, a barrier layer that contains ethylene-vinyl alcohol.
Oxygen exposure can cause plastic products to break down prematurely through a process known as oxidation. Affected polyethylene inserts can wear out prematurely and lead to complications with the implants.