Johnson & Johnson's ($JNJ) DePuy arm is recalling multiple lots of an orthopedic implant part prone to fracturing in some cases, and the FDA slapped its most-serious Class I status onto the effort. Limb loss is listed as one of the risks.
At issue is the lower extremity dovetail intercalary component, used with DePuy's Limb Preservation System, which helps reconstruct severe soft tissue and bone defects in the knee caused by tumors, trauma, infections or other issues. The part can replace portions of the femur or tibia. But, as regulators note in their recall notice, there's a risk that the component can cause an implant fracture, which in turn could lead to more surgery and ailments from pain to loss of mobility, loss of limb or neurovascular injuries.
Patients weighing more than 200 pounds and those who are highly active are at particular risk, the FDA said. Sixteen lots of the part are affected by the recall, and they were manufactured and distributed between Feb. 2007 and May 2013.
DePuy began its initial recall on July 11 with a notice to distributors, hospitals and surgeons, and the FDA assigned the Class I designation this week.
This isn't the only problem with the company's Limb Preservation System. In February, J&J/DePuy recalled the diaphyseal sleeve shipped with the product, cautioning that it could fracture as patients walk. The FDA assigned a Class I recall to that part, too. The sleeve is designed to help fit the Limb Preservation System implant in place.
The FDA is asking healthcare professionals and consumers to report any problems they have through the company's MedWatch program online.
- here's the FDA's notice