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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Exactech Equinoxe Reverse Shoulder Liners Recalled for Dimensional Specification

Agency Publication Date: September 12, 2025
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Summary

Exactech, Inc. has issued a voluntary recall for approximately 72,876 Equinoxe Reverse Shoulder Humeral Liners used in shoulder replacement surgeries. These polyethylene liners were found to have dimensions that fall outside the required specifications listed in the product labeling. This manufacturing issue affects several model sizes, including 38mm and 42mm versions manufactured in the United States.

Risk

The incorrect sizing of the humeral liner's articular surface can lead to improper fit or joint instability within the shoulder implant. This defect may cause premature wear of the device, restricted range of motion, or the need for revision surgery to correct the alignment of the shoulder joint.

What You Should Do

  1. This recall involves Exactech Equinoxe Reverse Shoulder Humeral Liners sold under model (REF) numbers 320-38-00, 320-38-03, 320-42-00, 320-42-03, 322-38-00, 322-38-03, 322-42-00, and 322-42-03.
  2. Identify affected products by checking the catalog or REF number and Unique Device Identifier (UDI) printed on the product packaging or listed in surgical records. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. If you have already received one of these implants, contact your surgeon or healthcare provider to discuss your specific clinical situation and any necessary follow-up monitoring.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Exactech Equinoxe, Reverse Shoulder Humeral Liners (320 Series)
Variants: 145-DEG PE 38MM HUM LINER +0, 145-DEG PE 38MM HUM LINER +2.5, 145-DEG PE 42MM HUM LINER +0, 145-DEG PE 42MM HUM LINER +2.5
Model / REF:
320-38-00
320-38-03
320-42-00
320-42-03
Serial Numbers:
All Serial Numbers
UDI:
10885862086655
10885862086662
10885862086693
10885862086709

Quantity: 61,334 UNITS

Product: Exactech Equinoxe, Reverse Shoulder Humeral Liners (322 Series)
Variants: 145-DEG PE 38MM HUM LINER +0, 145-DEG PE 38MM HUM LINER +2.5, 145-DEG PE 42MM HUM LINER +0, 145-DEG PE 42MM HUM LINER +2.5
Model / REF:
322-38-00
322-38-03
322-42-00
322-42-03
Serial Numbers:
All Serial Numbers
UDI:
10885862593832
10885862593849
10885862593917
10885862593924

Quantity: 11,542 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97459
Status: Active
Manufacturer: Exactech, Inc.
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 2 products (61,334 UNITS; 11,542 units)
Distributed To: California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.