The FDA has issued a recall of Blackstone Medical's ICON Modular Fixation System -- a collection of components allowing the surgeon to assemble a construct that includes screws, connectors and rods -- because components in the system may fail after the devices have been implanted. The product has been marketed since June 2005.
Blackstone issued the voluntary recall after receiving reports of construct loosening in the early postoperative period. The company then verified the removal from distribution of remaining affected products that were not yet implanted. The firm has asked hospitals and surgeons to review their records to identify patients who have the recalled products and alert those patients.
The original recall, submitted by Blackstone to the FDA in December 2005, was subsequently classified as a Class I recall by the agency.
For more information, access http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html (http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html).