FDAClass IIDecember 8, 2021

28mm -4 Lfit V40 Head recall

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

Why was 28mm -4 Lfit V40 Head recalled?

There is a potential for the outer white Tyvek lid to debond 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 number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306

Product
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Recalling firm
Howmedica Osteonics Corp.
Distribution
Puerto Rico
Recall date
December 8, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls