CALAXO Bone Screws Causing Serious Pain

Dallas, TXThis little gadget might make you think that no device implants are safe to use. The CALAXO bone screw recall shows that even the most simple device—a bone screw—can still cause harm to patients. Although the CALAXO recall was announced in 2007, patients are now investigating a possible lawsuit against the maker of the CALAXO screw, alleging they were harmed by the use of the CALAXO bone screw.

As far as medical devices go, the CALAXO screw should have been fairly simple. The product was approved in March 2006, for use during Anterior Cruciate Ligament (ACL, which runs from the shin bone to the knee joint and thigh bone) reconstructive surgery. During such surgery, a replacement ligament is anchored in holes drilled into the patient's shin and thigh bones using screws. Prior to the CALAXO screw, doctors used metal screws that required additional surgery for removal, if the screws were removed at all. The CALAXO bone screw was designed to promote bone growth and meant to be absorbed into the patient's body, meaning that no additional surgery was required for removal.

The screw was made from bioabsorbable polymer and calcium carbonate and was believed to have a quicker recovery time than other screws. However, the screw was recalled in August 2007, after reports emerged of swelling, fluid build-up, screw fragmentation and pain in patients who received the CALAXO screws. Some patients required additional surgery to remove dead or infected tissue and bone as well as removal of screw fragments.

According to the FDA's recall, the screw was recalled because of patient reaction. "Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation," the FDA announcement said. The recall affected all lots and item codes of the CALAXO screw. A recall was also announced in the UK.

Symptoms of CALAXO side effects include swelling, pain and redness around the joint or incision and accompanying fever.

The CALAXO bone screw is manufactured by Smith & Nephew, Inc. It was released to great hype in 2006, with a Smith & Nephew executive announcing, "Our CALAXO Osteoconductive Interference Screw is formulated with chemicals that stimulate the bone surface within the tunnel and trigger the development of new bone, which over time replaces the implant. It's preferable to restore the bone tissue that has been removed to make way for the graft. CALAXO makes this possible."

The ACL stabilizes the knee and controls its front-to-back motion, preventing the knee from hyper-extending. Most ACL injuries occur in athletes participating in sports that involve a lot of jumping or quick and frequent change of direction.

If you were harmed by the use of a CALAXO bone screw during surgery, you may want to speak with a lawyer about your legal options. You likely incurred increased medical expenses as a result of the injury, as well as financial losses due to time off work for recovery. A lawyer can help to determine whether you are eligible for financial compensation.

However, it is important to act quickly as the Statute of Limitations may be running out. It is vital that you speak to a legal professional sooner rather than later to ensure that all legal avenues are still open to you.