The United Kingdom has issued the immediate recall of all CALAXO Osteoconducive Interference Screws, used in Anterior Cruciate Ligament (ACL) reconstructive surgery. The UK CALAXO screw recall, issued in August 2007, affects all lot numbers and all item codes for product distributed since 2006, when the medical device was approved for use. CALAXO, manufactured by the Endoscopy division of Smith & Nephew, has also been used in ACL reconstruction surgeries in the United States since its US approval in 2006.
The UK CALAXO recall was issued because of rare, but potentially serious, CALAXO side effects. Worldwide, a small percentage of patients who have had CALAXO screws implanted during ACL reconstructive surgery have experienced pre-tibial soft tissue swelling. This CALAXO injury, which produces symptoms similar to infection, often develops anywhere from 2 to 36 weeks following surgery.
Of those patients who suffer CALAXO injuries, many require surgical intervention involving local debridement, or the removal of damaged tissues surrounding the implantation site, and removal of remaining screw fragments. Some require surgical replacement of the screw or bone graft.
Though the United States has not issued a CALAXO recall, the risks of CALAXO injuries are possible for patients in the US implanted with this medical device during ACL reconstructive surgery. It is unclear at this point whether such a recall of CALAXO screws will take place in the United States.