NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Class I - DangerousWhat Should You Do?
- Check if you have this product: Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medacta Usa Inc
- Reason for Recall:
- A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
Product Codes/Lot Numbers:
Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
Distribution:
Distributed in: AL, FL, NH, CO, IL, SC, AR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0372-2023
Related Recalls
There is a potential for breakage of the small screw used to affix the anti-backout plate.
There is a potential for breakage of the small screw used to affix the anti-backout plate.
There is a potential for breakage of the small screw used to affix the anti-backout plate.