Synthes Recalls Every Fixation Nail System Sold Since 2004

Synthes Trauma has recalled every single Trauma Fixation Nail system sold in the U.S. since 2004. The company issued the voluntary recall on November 1.

During a validation test for a change to the company’s sterile packaging, it was discovered that the outer pouch, which holds a sterile, internal pouch, may have been compromised. The recall is not being undertaken on the basis of adverse events.

The company “strongly urges” customers to return the devices and replacement product will be provided once it becomes available. If however, returning the device adversely impacts a hospital’s ability to provide medical care, the hospital may choose to re-sterilize the product per company instructions.

Debbie Williams, DePuy Synthes Companies’ communications director, told OTW that a review of the company’s packaging process has identified improvements to the packaging process, which are now in place to prevent the issue from recurring. “We are already packaging and shipping nails with the new process and we are ready to re-process inventory that is being returned.”

Industry sources told us that competitors have ramped up production of their own fixation nails to take advantage of any gaps in the market.

Stan Mendenhall, editor and publisher of Orthopedic Network News told us that this was a big deal. He said most of the nails are used during hip fracture surgery. Mendenhall said Synthes’ share of cephalomed (the generic name) nails in 2011 was 31.6% of the market. With 347, 000 hospitalized hip fractures every year, of which 64% are treated with the nails, it makes this one of Synthes’ top sellers.

Read the Synthes Recall Notice here.