FDAClass IIAugust 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox recall

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301

Why was Arcos Modular Revision Hip System Standard Cone Prox recalled?

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

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/UDI : Lot Number UDI Number 626490 (01)00880304468030(17)310412(10)626490 679210 (01)00880304468030(17)310418(10)679210

Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Recalling firm
Biomet, Inc.
Quantity
N/A
Distribution
US Nationwide distribution.
Recall date
August 18, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls