The Calaxo screw was approved by the U.S. Food & Drug Administration (FDA) in 2006 to assist in the healing of reconstructive anterior cruciate ligament (ACL) surgery. However, the product has been the subject of numerous injuries, a recall and lawsuits. Here are the facts:

What is the Calaxo screw?

The Calaxo screw is used in reconstructive ACL surgeries as an alternative to the metal screws that have been used in the past. It is a bio-absorbable polymer and calcium device that was created to promote bone growth and reabsorb more rapidly in the body and provide patients with a quicker recovery time. The screw itself is used in surgery to hold the ligament graft in place and is supposed to be naturally absorbed into the body within one year.

The Calaxo Screw is manufactured by Smith & Nephew, a global medical technology business headquartered in London, with U.S. offices in Massachusetts, which specializes in Endoscopy, Orthopedic Reconstruction, Orthopedic Trauma and Advanced Wound Management products.

Injuries & recalls

Approved in March 2006, the Calaxo Screw was recalled only a year and a half later, in August 2007, after the FDA and Smith & Nephew received complaints about swelling, screw fragmentation and pockets of fluid build-up. The recall included all lot numbers and item codes for products distributed since its approval in 2006.

Product liability lawsuits

Several product liability lawsuits have been filed against the manufacturer and legal experts say that more are likely to be filed in the future. One of the problems with these lawsuits has been that patients simply don’t know whether a Calaxo screw was used in their ACL surgery – until they start having problems – and either they or their attorney review their medical records.

If you’ve been injured by the Calaxo screw, your first priority should be to seek medical attention. ACL injuries can be extremely painful and debilitating. Any adverse reactions to the product should be reported to the FDA’s Medwatch Program and patients who have been injured may want to discuss their situation with an experienced products liability attorney and explore their options.