By Ben Fox Rubin
The Food and Drug Administration said Johnson & Johnson (JNJ) unit Synthes last month initiated a recall on certain lots of bone putty, saying the medical product could catch fire during surgery.
The FDA gave the recall a Class I designation, its most serious type of recall.
The regulator said Synthes in early July issued a medical device recall letter, asking medical facilities to examine their inventories and immediately stop using specific lots of the putty. The product, called a hemostatic bone putty, is used to stop bone bleeding by creating a physical barrier along the edges of bones that have been damaged by trauma or cut during surgery.
The FDA said the putty could ignite under some conditions if contacted with certain surgical equipment.
The lots recalled were manufactured between July 6, 2011, and Dec. 14, 2011, and were distributed from Dec. 22, 2011, to June 25, 2012.
J&J in June completed its $19.7 billion purchase of medical-device maker Synthes. The health-care giant has worked to tackle a range of problem products, such as the bottles of children's Tylenol and other popular over-the-counter medicines, as well as some contact lenses and certain hip implants, that the company recalled due to manufacturing problems.
The company's shares closed Tuesday at $67.78 and were up 15 cents after hours. The stock is up 3.4% so far this year.
Write to Ben Fox Rubin at [email protected]
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