DePuy Orthopaedics, a unit of Johnson & Johnson, received data compiled from the National Joint Registry of England and Wales that found one in eight patients needed corrective surgery within five years. Females saw the highest rates.
About 93,000 of these hip replacement systems have been implanted worldwide, according to a company spokeswoman. This is J&J’s 11th recall since September.
The recall includes the ASR XL Acetabular System, a total hip replacement system sold worldwide and the ASR Hip Resurfacing System, a partial hip replacement available in countries outside the U.S.
The Food and Drug Administration (FDA) also ordered DePuy to stop marketing the TruMatch Personalized Solutions System and the Corail Hip System in the United States without the required approval, in violation of the Federal Food, Drug, and Cosmetic Act.
The FDA, Congress and federal prosecutors continues to scrutinize J&J over eight previous U.S. recalls since last September which includes millions of bottles of Tylenol and other pain relievers and cold medicines for children and adults.