In February 2022, Exactech recalled about 147,000 plastic inserts that were used in knee and ankle replacements because the plastic can wear out early, leading to failure of the implant and corrective surgery.
Patients may need another surgery if they experience symptoms like new or worsening pain, inability to bear weight on the knee or ankle, grinding sounds or other noises, swelling, or instability in the joint.
The recall involves plastic inserts — also known as the Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Inserts. These plastic inserts were designed to fit in between the metal parts of a knee or ankle replacement to cushion the joint.
Exactech recalled the plastic inserts because they were packaged in an “out-of-specification” vacuum-sealed bag that did not actually prevent oxygen from contacting the insert.
Exactech warned that early exposure to oxygen may cause the plastic insert to degrade more quickly, leading to premature device failure.
“Over time, oxidation can severely degrade the mechanical properties of [the implant], 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,” Exactech explained.
The recall covers about 147,732 knee and ankle replacements that have been implanted in the U.S. since 2004. The recall covers all plastic inserts that were packaged in the out-of-specification bags, “regardless of label or shelf life,” according to Exactech.
The following implants are affected by the recall:
- Exactech Optetrak knee implants
- Exactech Optetrak Logic knee implants
- Exactech Truliant knee implants
- Exactech Vantage ankle replacements
Source: US Exactech Recall Information