Exactech Provides Update on Recall of Its Knee and Ankle Arthroplasty Inserts

Gainsville, Fla.-based Exactech has expanded the Aug. 31, 2021, recall of its Exactech ultrahigh molecular weight polyethylene (UHMWPE) knee and ankle polyethylene inserts to include all inserts “packaged in nonconforming bags, regardless of label or shelf life.”

The company said that most of the inserts it has manufactured since 2004 were packaged in out-of-specification, nonconforming vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol that augments oxygen resistance.

Over time, oxidation can severely degrade the mechanical properties of UHMWPE, which, “in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery,” the company said.