FROM: FOOD AND DRUG ADMINISTRATION
AUDIENCE:
Surgery, Risk Manager
ISSUE:
There is the potential for Hemostatic Bone Putty to ignite if contacted with
electrosurgical cautery systems under certain conditions during
surgery.
BACKGROUND:
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.
RECOMMENDATION:
On July 5, 2012, Synthes issued a Medical Device Recall letter 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 had 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
