xactech first recalled only certain hip replacement devices due to premature wear without a known cause. This was labeled as a Class II recall -- the second most serious grade indicates that the "product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote."
By February 2022, the manufacturer expanded a voluntary recall for certain knee replacements and total ankle replacements packaged in the defective bags, regardless of the device's label or shelf life. An estimated 80% of knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.
Later that year, the company expanded its hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags.
"The FDA is working with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks," the agency said.
HOW MANY boomers have had joints replaced in the last 15 or 20 years??? WHO thinks to ask about recalls on devices inserted into you r body???
