FDA issues reminder on defective packaging of some Exactech joint replacement devices
Key takeaways:
- FDA warns of recalled Exactech joint replacement devices from 2004 to 2021.
- The devices were recalled due to defective packaging, which could lead to oxidation of the devices and subsequent device failure.
The FDA has issued a reminder to health care providers and patients about the risks of Exactech joint replacement devices from 2004 to 2021, which were recalled in 2021 and 2022 due to defective packaging.
According to an FDA press release, Exactech joint replacement devices between 2004 and 2021 were packaged in bags that were missing an oxygen barrier layer. The defect potentially exposed the devices to oxidation, a chemical reaction that degrades plastic over time. According to the release, oxidation of devices has been shown to accelerate wear, component cracking and fracture, which could lead to revision surgery.
However, the FDA did not recommend the surgical removal of well-functioning and asymptomatic devices. The FDA is working to assess whether any other joint implants from Exactech that had defective packaging may result in similar risks, according to the release.
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