NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platfor
Summary
The FDA issued a Class II for NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based compu by Medacta Usa Inc. Reason: A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the.
Details
Source
Device Recall
External ID
Z-0372-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product 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
Lot/Code Info: Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
Quantity Affected: 14 units
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.
Distribution
AL, FL, NH, CO, IL, SC, AR
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-27
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medacta Usa Inc has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medacta Usa Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medacta Usa Inc have FDA actions?
Medacta Usa Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0372-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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