Calaxo Screw Recall – Contact Us

The CALAXO® screw was in use from roughly March, 2006 to August, 2007. It is a bioabsorbable polymer and calcium carbonate device designed to promote bone growth and reabsorb more rapidly by the body, thus producing a quicker recovery time. If you had ACL surgery during this time and suspect a CALAXO® screw was used, you should contact us. 

In March, 2006 the CALAXO® screw from Smith & Nephew was approved for use in the U.S. In August, 2007 Smith & Nephew did an immediate recall following reports of swelling, pain, pockets of fluid build up, and screw fragmentation. According to their recall letter, in rare cases, patients have developed pre-tibial soft tissue swelling between 2 - 36 weeks after insertion of the CALAXO screw. Smith & Nephew stated: “because the area of swelling and soft tissue irritation can mimic the appearance of an infection, our medical experts recommend that consideration should be given to aspirating the area for routine cultures”. Some cases require further surgery involving debridement (removal of dead or infected tissue and bone) and removal of any remaining screw fragments.

In some cases, surgeons have further replaced the fragmented polymer screw with an alternate screw or bone graft.

2 Responses to “Calaxo Screw Recall – Contact Us”

  1. Petunia Says:

    This product sounds horrible. Surgery that requires screws is painful enough the first time, but to have to turn around and do it again because the product is faulty is awful. I’m glad to read that this product was only on the market for a short time. Nobody should have to be in that kind of pain.

  2. Cautious Says:

    Althought I do applaude the science behind the concept for the calaxo screw, I find it hard to believe that Smith & Nephew actually thought they had developed a “one size will fit and can be absorbed by all” alternative for metallic screws or bone grafts used for ACL surgery.

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