FDAClass IIJuly 5, 2023

REF 1975.14.500 recall

REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

Why was REF 1975.14.500 recalled?

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

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-DI: 08033390244824; All Lots

Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Recalling firm
Limacorporate S.p.A
Quantity
13 units
Distribution
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Recall date
July 5, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls