Exactech Optetrak Recall

Exactech Optetrak Recall

The Exactech Optetrak knee replacement system is recalled due to a number of defects. These problems include deficient tibial plates and nonconforming vacuum bags. If you are considering the Exactech Optetrak system, here are some things you should know. In addition to defect information, Exactech has a website where you can check for a serial number.

Exactech Optetrak knee replacement system

A class II FDA recall has been issued for Exactech’s knee replacement systems, including the Optetrak and Truliant models. These systems are comprised of plastic polyethylene inserts that were improperly packaged and could have been damaged by oxidation. This defect can lead to premature wear and tear of the components, which is not only painful, but could also cause further complications.

The company is also recalling some ankle and knee replacement systems made by another company, Abiomed. Some of these devices were manufactured between 2004 and 2022. Exactech advised patients to contact their doctors if they’ve undergone knee replacement surgery with one of these products. If your knee implants failed, do not undergo revision surgery. You may be eligible for a knee replacement lawsuit if you are a victim of this product recall.

Defective tibial plates

A recent Exactech knee recall has resulted in theĀ defective polyethylene inserts recall of tibial plates. These plates fit between the tibia and femoral component of a total knee replacement. They act as a cushion for the replaced knee and ankle joints. Unfortunately, there have been many reports of problems with the tibial plates. The defective products could be dangerous or even cause severe complications.

In the latest recall, Exactech has recalled polyethylene tibial plates used to repair damaged knees. The polyethylene inserts were packaged in vacuum bags without a critical secondary barrier layer of ethylene vinyl alcohol. If the defective polyethylene tibial plates are inserted into patients, they may wear out prematurely. The degradation of polyethylene may cause multiple medical complications, including component loosening, swelling, and bone damage. Patients may also experience difficulty walking.

Non-conforming vacuum bags

Exactech has expanded its earlier recall of OPTETRAK Comprehensive Knee Systems and is voluntarily recalling all knee and ankle arthroplasty polyethylene inserts and non-conforming vacuum bags. The recalls are being conducted in response to reports of patient injuries and revision surgeries. The company cites an issue with oxidation of plastic parts after they are implanted.

The issue stems from the fact that the plastic polyethylene components used in the replacement of the knee and ankle are packed in vacuum-sealed bags that do not meet the requirements set forth in the FDA’s regulations. Oxygen diffusion in these non-specification bags may increase the risk of premature component wear and oxidation, which could severely compromise the mechanical properties of conventional UHMWPE.

Implant failure rate

After the initial launch of Optetrak, Exactech was aware of the high failure rates associated with this device. The company was receiving reports of countless implant failures. In 2012, the company received a flood of complaints about Optetrak devices, including failures due to aseptic loosening, polyethylene wear, and pain from visible loosening. Exactech failed to alert doctors and patients about the problem, and continued to sell and promote the implant despite these reports.

This failure rate was not unexpected; in fact, it was a common problem with many implants. The Optetrak failed to meet expectations in almost half of cases. But the failure rate for the new device was far higher than that of other knee replacement devices, which is not surprising given the high failure rate of older ones. The company is now recalling its products because of the concerns about the product.