FDAClass IIMay 11, 2022

Non-Sterile Double Ended Trial Kit recall

Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical…

Why was Non-Sterile Double Ended Trial Kit recalled?

Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.

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?

Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506

Product
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical…
Recalling firm
restor3d Inc.
Quantity
14 units
Distribution
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Recall date
May 11, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls