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Have you experienced pain, discomfort or swelling in the knee following resconstructive Anterior Cruciate Ligament (ACL) surgery utilizing the CALAXO screw? If so, you should contact us immediately to learn about the recall and to protect your legal rights. The CALAXO® screw was in use from 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 United States. 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 and 36 weeks after insertion of the CALAXO screw. Smith & Nephew advise: “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 remaining screw fragments. In a few cases, surgeons have further replaced the fragmented polymer screw with an alternate screw or bone graft. The ACL helps to stabilize the kneee and controls front-to-back movement. It runs from the tibia (shin bone) through the knee joint and to the femur (thigh bone). During reconstructive surgery the replacement ligament, usually obtained from another part of the patients body, is inserted and anchored in tunnels that have been drilled in the shin and thigh bones using a screw device. Metal screws were traditionally used for this type of surgery, but remain in place unless further surgery is performed to remove them. The bioabsorbable CALAXO screw was developed to replace metal screws. This recall is important to you if you have undergone Anterior Cruciate Ligament resconstruction surgery and have had one of these devices installed. Although side effects are rare, they are potentially serious. The symptoms of the side affects which can mimic the appearance of an infection are: - Swelling around the joint or incision area
- Redness around the incision
- Constant pain at the knee joint
- Accompanying fever to the above symptoms
If you have encountered side effects from the CALAXO screw, you are encouraged to participate in the Food and Drug Administration MedWatch program and report your problem using the online form. This Adverse Event Reporting Program is invaluable for the timely sharing of important safety information on drugs and medical devices. According to the FDA there are 68,285 units of these CALAXO screws in commerece affected by this recall. Was one of these used in your ACL surgery? Have you experienced swelling, pain, and secondary infection? If you have experienced any of these side effects you may have a claim for legal compensation. Contact The Fox Law Firm for superior legal representation. Additional information: FDA MedWatch Safety Reporting Program FDA Recalls
Medical Device Alert
The Fox Law Firm handles all CALAXO® claims on a contingency fee basis. This means there is no bill for legal services until after the firm receives a settlement or award for you in your potential claim. In all personal injury cases, it is extremely important that measures be taken promptly to preserve evidence, investigate the accident or toxic exposure in question, and to enable physicians, attorneys, or other expert witnesses to thoroughly evaluate any injuries. If you or a loved one or friend is injured and may have a potential legal claim, call The Fox Law Firm now at 1-866-FOX-FIRM, EXT 245. The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires. Do not delay! If you delay, and the statute of limitations time period expires, you may lose all your rights to file any claim for compensation of any kind. If you are not sure or need additional help, please fill out our form on this website or call us for help at 1-866-FOX-FIRM, EXT 245 (1-866-369-3476, EXT 245) or email us at
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. A member of our firm will call you as soon as possible to help you determine the possibility of filing a potential claim. For a free, no-obligation consultation with an experienced attorney regarding cases of personal injury and wrongful death, please submit our potential case intake form on this website for a free evaluation of your situation. We will respect the confidentiality of your information to the fullest extent. Form submissions are relayed to us through our highly secure servers. If you prefer, you may contact us at 1-214-528-4369, EXT 245.
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