FDAClass IIAugust 31, 2022

Hana/profx Classic Femoral Hook Right recall

HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

Why was Hana/profx Classic Femoral Hook Right recalled?

One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

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?

Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

Product
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Recalling firm
Mizuho OSI
Quantity
13 devices
Distribution
U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Recall date
August 31, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls