Synthes just issued a recall for its bone putty over concerns that the medical device product can catch fire.
The U.S. Food & Drug Administration (FDA) said some lots of the bone putty, manufactured by Johnson & Johnson’s Synthes unit, were recalled over fears the putty could catch fire when in contact with electrosurgical cautery systems during surgery, said Reuters. The product, Hemostatic Bone Putty, stops bone bleeds by implementing a physical barrier along bone edges that are traumatized or cut during surgery.
The recall, classified with the FDA’s strongest designation, a Class I, was implemented on July 5 when Synthes issued a medical device recall letter asking medical facilities to examine inventory and to immediately stop using the identified parts and lot numbers of the Hemostatic Bone Putty. Class I recalls are described by the agency as not only the FDA’s most serious type of recall, but also involving situations in which there exists a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
The recalled Hemostatic Bone Putty was manufactured between July 6, 2011 and December 14, 2011. The FDA indicated that the defective Synthes putty was distributed from December 22, 2011 to June 25, 2012. The recall affects all lots of the Hemostatic Bone Putty and the following Part Numbers: 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S.
Synthes can be reached at 1.610.719.5450, Monday through Friday, from 7:45 a.m. to 5:30 p.m., Eastern Time (ET), and is located at Synthes USA HQ, Inc., 1302 Wrights Lane, East West Chester, Pennsylvania, 19380. Facilities in possession of the recalled Synthes putty are asked to call 1.800.479.6329 to obtain a Return Authorization Number; facilities should then complete the verification form and return both the form and the identified product to Synthes. Facilities that did not have the identified, recalled product in stock were asked to complete and return the verification form to Synthes acknowledging receipt of the Medical Device Recall letter.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX: Online at www.fda.gov/Medwatch/report.htm; by telephone at 1.800.FDA.1088 (1.800.332.1088); or, by returning FDA form 3500, available on the MedWatch “Download Forms” page, by mail, to the address on the pre-addressed form or by fax to 1.800.FDA.0178.
This is not the first time Synthes has made news over a bone product. In a related matter with a different Synthes bone product, we recently wrote that the family of a woman who died on the operating table during an unapproved trial of the Norian bone cement product filed a lawsuit against Johnson & Johnson’s Synthes unit, claiming the company and its Norian unit “concealed the illegality, experimental nature and substantial risks of the surgery.”
As we’ve reported previously, the FDA approved the Norian product for use elsewhere in the body, but not the spine. In fact, its FDA-approved label warns against use in the spine, and studies have shown that such use can cause clots that could become lodged in the lungs, leading to death. The Norian bone cement was pulled from the market after Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures. Synthes and its Norian unit agreed in 2010 to plead guilty to federal charges that, between 2002 and 2004, they conspired to conduct unauthorized clinical trials using the bone cement in a type of spinal procedure. The company agreed to pay $24 million in fines to settle the charges, while four former Synthes executives pleaded guilty to one misdemeanor count each for their roles in the case.