CHICAGO - Johnson & Johnson, whose consumer unit has been plagued by massive recalls over the past year, said Thursday that its orthopedic unit was voluntarily recalling two hip-replacement systems.
J&J's DePuy Orthopaedics said it was recalling its ASR XL Acetabular System and ASR Hip Resurfacing System, both used in hip-replacement surgery, because of the number of patients requiring a second hip-replacement procedure, or a revision.
About 93,000 people globally have the ASR hip implant.
After five years, 13 percent of patients with complete hip replacements and 12 percent with resurfacing devices needed a second operation, known as a revision, according to unpublished data from a British registry, the New Brunswick, N.J.- based company said Thursday. Sales of the two devices were discontinued last year, J&J spokeswoman Mindy Tinsley said.
"We regret that this recall will be concerning for patients, their family members and surgeons," David Floyd, president of DePuy Orthopaedics, J&J's devices unit, said in a statement.
A spokeswoman said the company is evaluating how much of a financial impact, if any, the recall will have.
The recall comes just days after the Food and Drug Administration warned DePuy to stop marketing its Corail Hip System for unapproved use and about a week after J&J's Vision Care recalled about 100,000 boxes of 1-Day Acuvue TruEye lenses overseas.
The ASR Hip Resurfacing System was introduced in 2003 and is approved for use only outside the United States. The ASR XL Acetabular System was launched in 2004 and has been available worldwide.
J&J has more than 250 operating companies making products from heart devices to baby shampoo. Over the past year, J&J's reputation has been tarnished by recalls of Tylenol and other nonprescription drugs brands.