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Exactech Recall Information

This is an informational page for patients to learn facts about a specific recall. Click the links below to see if your implant is affected by a recall.

2025

Important Patient Information Regarding the Equinoxe Shoulder System 

About the Equinoxe® Shoulder System:

There are two types of shoulder replacement.

Anatomic Shoulder Replacement

In this procedure, the surgeon will remove the damaged bone and cartilage. The head of the humerus is then removed and a metal stem is placed into the humeral canal. This provides a stabilizing anchor for the head.

Anatomic Shoulder Replacement
Anatomic Shoulder Replacement

Reverse Shoulder Replacement

In this procedure, the anatomy of the shoulder is reversed by attaching a metal ball (glenosphere) to the glenoid and the plastic socket (humeral liner) to the upper humerus. A reverse shoulder replacement empowers your deltoid to become the main functioning muscle in the absence of a healthy rotator cuff.

Reverse Shoulder Replacement
Reverse 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 0.5 mm. 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 medical device recall of specific humeral liners.

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 follow-up, per each surgeon’s standard, is recommended.

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

The following products are affected:
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Item NumberProduct DescriptionBrand NameUDI
320-38-00REVERSE SHOULDER,38mm Humeral Liner,+0mmEquinoxe 10885862086655
320-38-03REVERSE SHOULDER,38mm Humeral Liner,+2.5mmEquinoxe 10885862086662
320-42-00REVERSE SHOULDER,42mm Humeral Liner,+0mmEquinoxe 10885862086693
320-42-03REVERSE SHOULDER,42mm Humeral Liner,+2.5mmEquinoxe 10885862086709

Previous

Connexion GXL & Conventional Hip Liners

This is to inform you of recent observations made by Exactech regarding the clinical performance of Connexion GXL and conventional polyethylene acetabular liners sold in the United States. The product-specific information is listed in the links below.
The following products are affected:

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Product NumberProduct DescriptionARTG
130-XX-XXGXL NUETRAL LINER287411
132-XX-XXNV GXL LNR, LIPPED287411
136-XX-XXNV GXL LNR, +5LAT287411
138-XX-XXNV GXL LNR, 10 DEG FACE CHANGING287411

Exactech Hip 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):

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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Product NumberProduct DescriptionARTG
Knee Recall
208-2X-XXOptetrak Tibial Insert, CC w/ Retaining Screw277743
264-2X-XXOptetrak RBK PS, Hi-Flex Tibial Insert277745
200-2X-XXOptetrak Tibial Insert, CR Slope Neutral, size 1-5278343
200-5X-XXOptetrak Tibial Insert, CR Slope Neutral, size 0278343
200-6X-XXOptetrak Tibial Insert, CR Slope +, size 1-5278343
200-7X-XXOptetrak Tibial Insert, CR Slope ++, size 1-5278343
02-012-51-XXXXOptetrak Logic Tibial Insert, CRC284907
02-012-47-XXXXOptetrak Logic Tibial Insert, CR Neutral285442
02-012-48-XXXXOptetrak Logic Tibial Insert, CR Slope +285442
02-012-49-XXXXOptetrak Logic Tibial Insert, CR Slope ++285442
02-012-35-XXXXOptetrak Logic Tibial Insert, PS285502
02-012-44-XXXXOptetrak Logic Tibial Insert, PSC285503
204-2X-XXOptetrak Tibial Insert, PS285677
02-012-38-XXXXOptetrak Logic RBK Tibial Insert, Posterior Stabilized285911
244-2X-XXOptetrak Tibial Insert, Hi-Flex, PS286119
Ankle Recall
350-41-XX/350-42-XXMobile-bearing total ankle prosthesis308700

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 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:

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Catalogue NumberProduct NameARTG Number
200-02-26, 200-02-29, 200-02-32, 200-02-35,
200-02-38, 200-02-41
Optetrak Three Peg Patella 26MM – 41MM279041

Learn about your implant

The knee is the largest joint in the body and is made up of the lower end of the thigh bone (femur), the upper end of the shin bone (tibia), and the knee cap (patella).

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 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.

Product Number
Product Description
ARTG
314-01-0XEQUINOXE GLENOID, KEELED ALPHA159609
314-01-1XEQUINOXE GLENOID, KEELED BETA159609
314-02-0XEQUINOXE GLENOID, PEGGED ALPHA264381
314-02-1XEQUINOXE GLENOID, PEGGED BETA264381
314-02-2XEQUINOXE POST AUG GLENOID, LEFT278648
314-02-3XEQUINOXE POST AUG GLENOID, RIGHT278648
314-13-0XEQUINOXE CAGE GLENOID, ALPHA270232
314-13-1XEQUINOXE CAGE GLENOID, BETA270232
314-13-2XEQUINOXE CAGE GLENOID, POST AUG, LEFT293762
314-13-3XEQUINOXE CAGE GLENOID, POST AUG, RIGHT293762
320-36-0X
320-38-0X
320-42-0X
320-46-0X
EQUINOXE 145-DEG PE 36 – 46MM HUM LINER264172
320-36-1X
320-38-1X
320-42-1X
320-46-1X
EQUINOXE 145-DEG PE 36 – 46MM CONST HUM LINER279721

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
Anatomic System
Reverse System

To learn more about your implant, click here