NextAR Shoulder Surgical Technique recall
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse…
Why was NextAR Shoulder Surgical Technique recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
- Product
- NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse…
- Recalling firm
- Medacta Usa Inc
- Quantity
- 14 units
- Distribution
- AL, FL, NH, CO, IL, SC, AR
- Recall date
- December 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)