Stryker (NYSE:SYK) said yesterday that the cost of the recalls of its Rejuvenate and ABG II hip implants could top $1 billion, nearly double its prior estimate.
The Kalamazoo, Mich.-based orthopedic medical device company said in a regulatory filing that it now expects the recalls to cost between $700 million and $1.13 billion.
Stryker’s previous estimate for the cost of the recalls was $400 million to $600 million, according to a separate filing.
"Product liability lawsuits relating to this voluntary recall have been filed against us. As previously announced, we intend to reimburse implanted patients for reasonable and customary costs of testing and treatment services, including any necessary revision surgeries. We continue to work with the medical community to evaluate the data and further understand this matter and the associated costs," according to the most recent filing. "The ultimate cost to entirely resolve this matter may be materially different than the amount of the current estimate and accruals and could have a material adverse effect on our financial position, results of operations and cash flows."
Stryker announced the recalls in July 2012, saying the Rejuvenate and ABG II devices may be prone to "fretting and/or corrosion at or about the modular-neck junction," which may lead to pain, swelling and adverse reactions in surrounding tissue.
The hip implants aren’t the only recalls plaguing Stryker. In June 2012 the company yanked its Neptune surgical waste management device after receiving reports of serious injuries and 1 death. And earlier this year the FDA slapped its recall of 5 lots of the Oasys midline occipital plate with Class I status, denoting a product that could result in serious injury or death.
The Rejuvenate, ABG II and Neptune recalls combined to push Stryker’s bottom line down nearly 71% during the 3rd quarter.
SYK shares were trading at $73.72 apiece as of about 10:20 a.m. today, down 0.3%.