FDAClass IIMarch 13, 2019

Comprehensive Reverse Shoulder System Glenosphere Mini recall

Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder…

Why was Comprehensive Reverse Shoulder System Glenosphere Mini recalled?

The product was potentially being packaged without a taper adapter.

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?

Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950

Product
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder…
Recalling firm
Zimmer Biomet, Inc.
Quantity
52
Distribution
US Distribution to states of:: AR, KY, and WA.; Internationally to: Australia and Japan.
Recall date
March 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls