FDAClass IIJanuary 18, 2017

GoDirect Screw-Retaining Top recall

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Why was GoDirect Screw-Retaining Top recalled?

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

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 #75808

Product
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
14
Distribution
U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls