Class I Medical Device Recall: Synthes Hemostatic Bone Putty
Recall Class: Class I
Date Recall Initiated: July 5, 2012
Product: Synthes Hemostatic Bone Putty
Manufacturing Dates: July 6, 2011 - December 14, 2011
Distribution Dates: December 22, 2011 - June 25, 2012
The affected models and lot numbers can be found below:
|Part Description||Part Number||Lot Number|
|Hemostatic Bone Putty||08.901.001.97S||ALL|
Use: 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.
Synthes USA HQ, Inc.
1302 Wrights Lane East
West Chester, PA 19380
Reason for Recall: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Public Contact: Questions should be directed to Synthes at 1-610-719-5450, Monday through Friday from 7:45 am to 5:30 pm, Eastern Time.
FDA District: Philadelphia
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.
Facilities that did not have the identified product in stock were asked to complete and return the verification form to Synthes acknowledging receipt of the Medical Device Recall letter.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.