FDAClass IIFebruary 7, 2024

Centered Glenosphere w/Screw recall

Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

Why was Centered Glenosphere w/Screw recalled?

Centered glenosphere box may contain an eccentric glenosphere.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI-DI: 03701037309551, Lot: U0191

Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Recalling firm
FX SHOULDER
Quantity
4
Distribution
US Nationwide distribution in the state of NJ.
Recall date
February 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls