--强生公司目前决定召回其生产的多批次骨科植入部分配件，原因是FDA认为该种配件很容易出现断裂等质量问题。在召回声明中，公司表示这种配件可能会造成患者的疼痛或者行动不便等原因。体重在200磅以上或者活动频繁的患者更易有此风险。此次召回的产品共有16批次，均生产于2007年2月到2013年5月之间。

详细英文报道：

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.