Medact: NextAR Shoulder surgical tools require checking for coracoid bone stability to prevent fractures. Verify patient conditions before use to avoid bone injury during surgery.
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.
Medacta's NextAR Shoulder surgical tools require checking for coracoid bone stability before use to prevent fractures. This recall is for surgeons performing reverse shoulder replacements.
The surgical technique requires verifying coracoid bone stability before placing the target holder. If the bone is weak or unstable (e.g., due to osteoporosis), it could fracture during surgery, causing injury.
Surgeons using Medacta's NextAR Shoulder surgical tools for reverse shoulder replacements in the US. Patients with osteoporosis or weak coracoid bones are at higher risk of fracture.
The NextAR Shoulder Surgical Technique and Shoulder NextAR RSA Platform are used for reverse shoulder replacements. They were sold in the US with document reference code 99.81NEXTAR.12US (Revisions 02 and earlier).
Check for coracoid bone stability and patient conditions like osteoporosis before using the device.
The recall is to warn surgeons to verify coracoid bone stability before using the device to prevent fractures.
The official notice does not specify a remedy; surgeons should verify patient conditions before use.
Yes, if the coracoid bone is weak or unstable, it could fracture during surgery.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-0372-2023 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-0372-2023 from Medacta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
