FDAClass IIApril 25, 2018

Southern Implants recall

SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a…

Why was Southern Implants recalled?

The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.

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 code: 251J00d2

Product
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a…
Recalling firm
Southern Implants, (Pty.) Ltd.
Quantity
49 units
Distribution
US, South Africa, France
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls