In August of 2007, only a year after initial approval, the FDA recalled the Calaxo Osteoconductive Interference Screw sold by orthopedic company Smith & Nephew.

The recall came after a sudden increase in injuries to patients who had the bioabsorbable screws implanted in their knees during anterior cruciate ligament (ACL) surgery. The screws were found to break and fracture leaving fragments in the surrounding tissue. Patients reported suffering from painful swelling, infection, and fluid build-up in repaired knees. The post injury diagnosis is commonly referred to as “pre-tibial soft tissue swelling”.

As a result of the splintering of the device, some patients had to undergo local debridement which requires the surgical removal of affected tissue and/or bone. Aspiratation of the knee and analysis of the fluid for infection and particulate matter is important as a first step towards diagnosing the issue. However, a scope of the area in which the screws were affixed may be necessary.

If you, or someone you know, has endured difficulties with the Calaxo screw, possibly after ACL surgery, please contact us to discuss your legal rights.