Zimmer Inc. has issued a Class II recall for a knee replacement component due to reported device failures.
According to the FDA, the Natural-Knee II Durasul Patella product has been recalled because “the pegs on the back side of the patella have sheared at the peg/patella interface.” The product was also found to have “lower fracture fatigue strength than other similar products.”
So far there have been reports of 16 incidences where the patella peg sheared out.
The FDA describes a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
If you or a loved one has been harmed by an unsafe medical device, you may be entitled to compensation. Contact Sokolove Law for a free legal consultation and to learn about your options.