US Exactech Recall Information

Important Patient Information Regarding the Equinoxe Shoulder System 

About the Equinoxe^® Shoulder System:

There are two types of shoulder replacement.

This information applies to patients who received an Equinoxe Reverse Shoulder replacement. It was recently discovered that some Equinoxe Reverse Shoulder polyethylene humeral liners have an articular surface center of rotation slightly out of specification, up to 0.02 inches. Not all reverse shoulders were impacted.

Reverse Humeral Liner surface shown 1) as specified and 2) with three possible manufacturing shifts of the center of rotation. Blue indicates specified center of rotation, orange indicates shifted position.

Due to this deviation from the designed center of rotation, we are conducting a voluntary medical device recall of specific humeral liners.

If your implant is within the scope of this recall, this does not mean that the shoulder component needs to be replaced.
The dimensional shift was identified through Exactech’s internal quality inspection. It may slightly decrease active range of motion by up to 1 degree. There are no related complaints or adverse events reported.

Normal patient monitoring and follow-up per your surgeon’s standard of care is recommended. Revisions of well performing shoulders using “shifted” humeral liners is not recommended.

If you have questions, please contact humeralCOR@exac.com.

The following products are affected:
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Knee and Ankle Polyethylene

This is to inform you of recent observations made by Exactech regarding the clinical performance of our Knee and Ankle polyethylene inserts.

The following products are affected:

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Exactech Knee & Ankle Polyethylene Patients: What to do

Please use the following link to see if your hip liner is affected by this recall (you will need your serial number):

Important Patient Information Regarding Exactech Polyethylene Patellas

This is an informational notice about Exactech polyethylene patellas that were packaged in nonconforming bags.

We are conducting a voluntary medical device recall for nonconforming packaging in order to retrieve unused inventory. If a patient has a patella component within the scope of this recall, this does not mean that the patella component needs to be replaced.

If you are experiencing any new or worsening knee swelling, pain while walking, inability to bear weight, grinding or other noise, instability, or any new symptoms of clicking in your knee, you should contact your health care provider for further investigation of the cause of the new or worsening symptoms. These could include implant factors as well as patient factors (age, sex, physical characteristics, activity level, etc.), surgical factors (technique, alignment, etc.), and postoperative rehabilitative factors. Normal patient monitoring and follow-up per your surgeon’s standard of care is recommended. Revisions of well performing patellas from nonconforming packaging are not recommended.

You can look up your information here to learn if an implant that was packaged in nonconforming packaging was used during your procedure.

The following products are affected:

Scroll right to view the full table on mobile devices.

Important Patient Information Regarding the Equinoxe Shoulder System

This is an informational notice about Equinoxe Shoulder polyethylene humeral liners and anatomic glenoids that were packaged in nonconforming bags.

We are conducting a voluntary medical device recall for nonconforming packaging in order to retrieve unused inventory. If a patient has a shoulder component within the scope of this recall, this does not mean that the shoulder component needs to be replaced.

If you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device, you should contact your health care provider for further investigation of the cause of the new or worsening symptoms, which could include implant factors as well as patient factors (age, sex, physical characteristics, activity level, etc.), surgical factors (technique, alignment, etc.), and postoperative rehabilitative factors. Normal patient monitoring and follow-up per your surgeon’s standard of care is recommended. Revisions of well performing shoulders from nonconforming packaging are not recommended.

If you would like to read the full FDA communication, <click here>. An excerpt is below:

“Recommendations for Patients:

• • If your Equinoxe Shoulder System is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove a well-functioning device.
  • Contact your health care provider if you have an Equinoxe Shoulder System implanted and you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device.”

You can look up your information here to learn if an implant that was packaged in nonconforming packaging was used during your procedure. Please use the following link to see if your shoulder liner is affected by this recall (you will need your serial number):

The following products are affected:

Scroll right to view the full table on mobile devices.

More about the Equinoxe^® Shoulder System:

The platform system allows conversion of a primary or fracture shoulder replacement to a reverse without the need to remove the already well-fixed stem. The high-quality implants are designed to:

• Help match each individual patient’s bone structure
• Preserve a patient’s natural anatomy
• Work in a variety of procedures
• Address unique clinical challenges

To learn more about your implant, click here