The CALAXO screw is a bio-absorbable polymer and calcium carbonate medical device designed to promote bone growth and reabsorb more rapidly by the body, with the intention of producing a quicker recovery time. It was approved by the FDA in March 2006 but recalled in August 2007 following reports of swelling, pain, pockets of fluid build up, and screw fragmentation.
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Calaxo Bone Screw
The Calaxo screw recall affects all lot numbers and all item codes for product distributed since its approval in 2006. The medical device, manufactured by the Endoscopy division of Smith & Nephew, is used during reconstructive Anterior Cruciate Ligament (ACL) surgery.
The ACL runs from the shin bone, or tibia, of the lower leg, through the center of the knee joint, and up to the thigh bone, or femur. The ACL helps to stabilize the knee and prevent hyperextension and excessive rotation of the knee joint. The ligament also controls front and back movement.
Reconstructive surgery to replace the ligament and return normal movement and functioning to the knee joint area is often required if the ACL is torn or sustains a similar injury. Usually, surgeons use ligaments harvested from another area of the patient's body to replace the ACL and screws are often used to secure the graft. Historically, metal screws were used but the CALAXO screw was developed to replace metal screws.
Symptoms of CALAXO Screw Injury
The symptoms of CALAXO injury may include:
Â· Redness around the incision site
Â· Constant or increased pain at the surgery site
Â· Swelling near the incision area
Swelling produces symptoms similar to infection and often develops anywhere from 2 to 36 weeks following surgery.
If you have suffered any adverse reactions to the CALAXO screw, you should seek medical help right away. As well, you are encouraged to report any symptoms to the FDA's Medwatch Program—a Safety Information and Adverse Event Reporting Program that allows consumers and medical care providers to voluntarily report any possible adverse events associated with medical products.
As well, if you have suffered an injury due to the CALAXO screw, you may also want to seek legal help: you may be entitled to compensation for the cost of additional medical care, loss of income resulting from increased recovery time and pain and suffering.
Smith & Nephew, a global medical technology business specializing in Endoscopy, Orthopaedic Reconstruction, Orthopaedic Trauma and Advanced Wound Management products, has more than 8,500 employees, operates in 33 countries around the world and last year generated sales of nearly $2.6 billion.
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Last updated on Mar-14-09
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