FDAClass IIFebruary 21, 2018

Multi-Unit Abutment Angled recall

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous…

Why was Multi-Unit Abutment Angled recalled?

Abutments are unable to accept the final abutment screw

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?

REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

Product
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous…
Recalling firm
Keystone Dental Inc
Quantity
20 units
Distribution
US Nationwide Distribution in the states of ND, NJ & MA
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls