Look out. That bone putty could ignite!
A hemostatic bone putty made by Synthes, USA, Inc., before its merger with Johnson & Johnson, is the subject of a Class I Recall. According to an August 21, 2012 notification by the FDA, there is a potential for the putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Hemostatic bone putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The affected models and lot numbers can be found in the FDA Recall Notice.
Synthes issued a Medical Device Recall letter on July 5, 2012, requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the hemostatic bone putty.
If a facility has the affected product in stock, they were asked to call 1-800-479-6329 to obtain a Return Authorization Number, complete the verification form and return both the form and identified product to Synthes.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online: www.fda.gov/MedWatch/report.htm. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The putty in question was manufactured between July 6, 2011 and December 14, 2011 and distributed from December 22, 2011 to June 25, 2012.
The product was submitted for 510(k) clearance on October 2011 and received a Substantially Equivalent designation by the FDA on December 13, 2011.
