FDAClass IIMay 1, 2024

Vanguard Knee System AS Tibial Bearing / DCM ArCom recall

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective…

Why was Vanguard Knee System AS Tibial Bearing / DCM ArCom recalled?

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

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?

Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;

Product
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective…
Recalling firm
Biomet, Inc.
Quantity
19 units (1 US, 18 OUS)
Distribution
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Recall date
May 1, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls