FDAClass IIIFebruary 13, 2019

Ascension Modular Radial Head recall

Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

Why was Ascension Modular Radial Head recalled?

The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

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?

170691

Product
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Recalling firm
Ascension Orthopedics, Inc
Distribution
Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Recall date
February 13, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls