FDAClass IIAugust 3, 2022

HammerTube Implant recall

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Why was HammerTube Implant recalled?

Due to Titanium plasma coating not present implant.

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?

Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

Product
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Recalling firm
Paragon 28, Inc.
Quantity
9 implants
Distribution
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Recall date
August 3, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls