Johnson & Johnson's ($JNJ) Synthes unit launched a recall of its Hemostatic Bone Putty, warning that the implant could catch fire if exposed to cauterization systems during surgery, and the FDA has slapped its most serious label on the affair.
On July 5, Synthes sent recall letters to its customers, warning that lots of the putty manufactured between July 6, 2011 and Dec. 14 were prone to igniting when they interacted with electrosurgical devices, and the FDA deemed it a Class I on Tuesday.
Hemostatic Bone Putty is used to halt bone bleeding by creating a barrier along bones that have been cut due to trauma or as part of a surgical procedure.
The FDA reserves its Class I tag only for recalls that carry significant risk of serious injury or death, and the agency is urging health professionals and patients to report adverse events related to the putty through its online MedWatch system.
This isn't the sort of headline J&J had in mind when it spent $21.3 billion on Synthes, a deal that just closed this summer. J&J shipped off its DePuy unit--no stranger to recalls itself--to Biomet for $280 million in order to get the deal done. Now J&J faces billions in lawsuits over DePuy's faulty all-metal hip implants and more litigation tied to the company's Gynecare Prolift vaginal mesh, which plaintiffs say J&J kept on the market despite mounting safety concerns.
- read the FDA recall notice
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