FDAClass IIJuly 15, 2020

Irix-C Forceps Inserter recall

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Why was Irix-C Forceps Inserter recalled?

The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

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?

LOT: XS1920458A

Product
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Recalling firm
XTANT Medical
Quantity
4 units
Distribution
AZ, TX and WV.
Recall date
July 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls