Stryker ($SYK) is recalling two metal-on-metal hip implants, halting worldwide production of the devices amid concerns of fretting and corrosion.
The company has pulled Rejuvenate and ABG II modular-neck stems, citing post-market surveillance data in which some patients suffered pain and swelling due to device failure, Stryker said in a statement. These complications might be predictive of a trend, according to the company, and one of its vice presidents said Stryker will continue to examine the data and work with the medical community to understand the risk of all-metal implants.
Stryker said it has notified doctors and regulators of the recall, and the company is urging patients who have received the implants to contact their surgeons. The firm also posted a question-and-answer page about the recall on its website.
The recall follows an increase in scrutiny for metal-on-metal hip techs by the FDA, which last week convened a panel of experts to debate the merits of the failure-prone devices. Physicians said that while there are some benefits to all-metal implants, the risk of the devices breaking down and releasing metallic flotsam into the bloodstream is too great to warrant use.
Johnson & Johnson ($JNJ) recalled about 100,000 of its DePuy implants in 2010, and metal-on-metal hip replacements have gradually fallen out of favor among doctors as reports of device corrosion and a higher need for replacement have surfaced. The latest move by the FDA follows similar concerns in the U.K., where regulators and doctors groups have advocated against using all-metal techs.
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