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Bioabsorbable Screws, Calaxo, Etc. PDF Print E-mail

Bioabsorbable Screws, Calaxo, Etc.

Have you or a loved one 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 Calaxo recall and to protect your legal rights.

The CALAXO¬ģ 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¬ģ screw was used, you should contact us.

In March 2006 the CALAXO¬ģ 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, among other issues reported by patients who received the medical device during surgery.

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: ‚Äúbecause 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‚ÄĚ.

Some cases require further surgery involving debridement (removal of dead, necrotic, 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.  Such revision surgeries can have many complications and are particularly difficult for elderly patients.

The ACL helps to stabilize the knee 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, and was considered an advance over 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, and can have serious long-term health effects.

The symptoms which can mimic the appearance of an infection are, but are not limited to:

  • Swelling around the joint or incision area; redness and discomfort around the incision; constant pain or discomfort at the knee joint; accompanying fever to the above symptoms.

If you have encountered side effects or other issues due to 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 commerce affected by this recall. Was one of these used in your ACL surgery or a different type of surgery? Have you experienced swelling, pain, and secondary infection or other issues?

If you have experienced any of these side effects you may have a claim for legal compensation. Contact DrugRx Recall & The Mulligan Law Firm for legal representation.

Additional information:

 

FDA MedWatch Safety Reporting Program

FDA Recalls

Medical Device Alert

 


 

The Mulligan¬†Law Firm handles all CALAXO¬ģ 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 legal 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.  It is important to be aware that you should act quickly to avoid the passing of your statute of limitations.

If you or a loved one or friend is injured and may have a potential legal claim, call DrugRxRecall and The Mulligan Law Firm now at 1-888-446-8087 or fill out any form on this website. 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 1-888-446-8087.

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.

The Calaxo Bioabsorbable Screw And Your Legal Rights

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¬ģ 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¬ģ screw was used, you should contact us.

In March 2006 the CALAXO¬ģ 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 advised: ‚Äúbecause 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‚ÄĚ. Some cases require further surgery involving debridement (removal of necrotic, 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 knee and controls the 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 surgical 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, and doctors hoped this would be an advancement over earlier screw types.

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, and can be especially difficult for elderly patients.

The symptoms of the side affects which can mimic the appearance of an infection are:

  • Swelling around the joint or incision area
  • Fever
  • Redness around the incision location
  • Constant pain at the knee joint or other areas of surgical use of the screw

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 Drug Rx Recall & The Mulligan Law Firm for legal representation.

Additional information:

FDA Recalls

FDA MedWatch Safety Reporting Program

Smith & Nephew Recall Letter to Patients (PDF)

 


 

The Mulligan¬†Law Firm handles all CALAXO¬ģ 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 us now at 1-888-446-8087.

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 1-888-446-8087

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.

***

Drugs or medical devices on our web pages may or may not have been subject to any kind of recall.  Recall status may change at any time.  Always check with The FDA about current potential recall status of any drug or medical device.

Thank you for visiting our website.¬† The articles and content on this website were NOT written by medical professionals and shall not, at any time, be mistaken for medical advice of any kind.¬† Always consult with your licensed medical provider ‚Äď your doctor or physician ‚Äď prior to making any changes or decisions regarding your medical care.¬† Please read our entire user agreement on our main home website, www.drugrxrecall.com.¬†

 

 
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