The US Food and Drug Administration has issued a recall notice about a putty used in surgery that carries a risk of exploding.
Johnson & Johnson’s Synthes unit recalled its Hemostatic Bone Putty, and the FDA slapped its most serious label, Class I Recall, on the affair.
The FDA reserves its Class I tag for recalls that carry significant risk of serious injury or death, and the agency is urging health professionals and patients to report adverse events related to the putty through its online MedWatch system.
What Is The Homeostatic Bone Putty?
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.
On July 5, Synthes sent recall letters to its customers, warning that lots of the putty manufactured between July 6, 2011 and Dec. 14 were prone to igniting when they interacted with electrosurgical devices, and the FDA.
The risk is that “there is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.”
The letter identified the affected product along with the reason for recall; and requested that consignees immediately cease using the product, examine their inventory, and remove the product from inventory.
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.
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.
According to their own website, Synthes is a leading global medical device company. Through its five product groups (Trauma, Spine, Cranio-Maxillofacial, Biomaterials and Power Tools) it develops, produces and markets instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.[hr]