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: Accelerated wear, debris production, bone loss, component fatigue and component cracking or fracture that will require revision surgery to correct.

The FDA classified the recall as a Class 2 recall. This means the recalled products may cause temporary or medically reversible health issues.

Though Exactech said the packaging problems started around 2004, the Optetrak Knee system has been on the market since 1992. Data from Australian, New Zealand and United Kingdom registries have shown the implant has significantly higher overall revision rates compared to other knee implants, according to the company’s recall letter.

Prior to this recall, Exactech already faced Optetrak knee implant lawsuits where patients claimed the implant failed early, causing pain, instability and the need for revision surgery. Lawsuits say Exactech knew or should have known of the problems but failed to warn consumers and continued to sell defective devices.

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What to Do If Your Device Is Recalled

Patients with recalled Exactech knee or ankle implants suffering from new or worsening swelling, pain while walking, inability to bear weight, grinding or other noise, instability or any new symptoms of clicking in the knee or ankle should contact their providers for an evaluation. Health care providers may contact patients who received these devices to make sure that the devices are working properly.

Exactech doesn’t recommend surgery for patients who aren’t experiencing problems such as pain or difficulty walking. The company has set up a website for US Exactech Recall Information and provides instructions for how to make a claim for reimbursement of out-of-pocket damages related to recalled devices.