The health regulator said certain lots of bone putty made by Johnson & Johnson unit Synthes were recalled as there was potential for the putty to catch fire if it came in contact with electrosurgical cautery systems during surgery.
The Hemostatic Bone Putty is used to stop bone bleeding by creating a physical barrier along the edges of bones damaged by trauma or cut during a surgical procedure.
The recall, which has been classified as Class I, or the most serious type of recall, was initiated on July 5.
Synthes had issued a medical device recall letter on July 5 requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the putty manufactured between July 6, 2011 and December 14, 2011.
J&J has been hit by several recalls ranging from its consumer medicines Tylenol and Motrin to artificial hip implants. The company had also taken charges of more than $3 billion in the latest fourth quarter largely related to the recall of the defective artificial hips.
J&J shares were up marginally at $67.97 in afternoon trade on the New York Stock Exchange.
(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)