FDAClass IIFebruary 23, 2022

Dall Miles SM Grip and 2 1.6mm Homog CBL recall

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

Why was Dall Miles SM Grip and 2 1.6mm Homog CBL recalled?

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

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: 07613327013306; Lot Number: 87458602

Product
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Recalling firm
Howmedica Osteonics Corp.
Quantity
1 unit
Distribution
Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.
Recall date
February 23, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls