FDAClass IIMay 31, 2017

Legacy Full Contour Laboratory Abutment: 3.5mmD recall

Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD

Why was Legacy Full Contour Laboratory Abutment: 3.5mmD recalled?

Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

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?

89103, 83493, 78986

Product
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
151 units
Distribution
Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan
Recall date
May 31, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls