Managing Partner
Exactech issued a recall for thousands of polyethylene plastic inserts used in knee and ankle replacements because the plastic may wear early, leading to implant failure and revision surgery.
Recalled Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts fit in between metal components in knee and ankle replacements to cushion joints. The recall affects tibial inserts and liner components from the following knee and ankle replacement systems: Optetrak, Optetrak Logic, Truliant and Vantage.
Exactech recalled the devices because of out-of-specification packaging that didn’t adequately protect the inserts from oxygen exposure, according to the company’s Urgent Medical Device Correction letter sent to surgeons on February 7, 2022. Exposure to oxygen can cause the inserts to degrade over time and lead to early device failure.
The recall covers all knee and ankle inserts packaged in out-of-specification bags “regardless of label or shelf life.” The company confirmed that inserts manufactured since 2004 were packaged in out-of-specification bags, and about 147,732 devices have been implanted in the US since 2004.
Potential Problems Caused by Recalled Knee and Ankle Devices
Potential problems caused by Exactech’s recalled knee and ankle implants include: Component fatigue, component cracking or fracture that will require revision surgery to correct, accelerated wear, debris production and bone loss.
The FDA classified the recall as a Class 2 recall. This means the recalled products may cause temporary or medically reversible health issues.
