Exactech's implant troubles continue in 2024


Since orthopedic devicemaker Exactech began recalling hip, knee and ankle implants in 2021, the company has faced a wave of lawsuits from patients. Now, the FDA has issued a new warning regarding the company's shoulder joint replacement system. 

Here are five updates from Exactech's last year of warnings and recalls: 

1. The FDA issued a patient safety alert regarding Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and August 2021 due to a defect with the packaging. The defective bags used for packaging were missing an oxygen barrier layer that protects devices from oxidation, which can lead to faster device wear or failure and component cracking and fractures. 

2. As of October, Exactech was facing hundreds of lawsuits filed on behalf of 1,100 patients who say they received faulty joint implants. In a 2021 letter shared with surgeons, the company said a packaging defect caused plastic in a knee component to wear out prematurely.

3. In April, the FDA issued a followup reminder on recalled joint replacement devices. 

4. In February, attorneys filed a master complaint against Exactech that focused on 200,000 recalled devices. 

5. In January, a New York woman filed a lawsuit against Exactech alleging that the company  knew about issues with its Optetrak total knee implant.

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