Z-1386-2018Class II

SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement...

Name: Z-1386-2018 SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement...
Creator: Southern Implants, (Pty.) Ltd.
Published: 2018-03-08
License: https://open.fda.gov/license/

Southern Implants, (Pty.) Ltd. / initiated 2018-03-08 / Terminated / root cause: manufacturing process

FDA source

Southern Implants, (Pty.) Ltd. began a recall of 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 means for... on 2018-03-08. FDA classified it as Class II and gives the reason as "The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1386-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-08
Posted: 2018-04-16
Terminated: 2019-09-26
Recalling firm: Southern Implants, (Pty.) Ltd.
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 means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.
Quantity in commerce: 49 units
Distribution: US, South Africa, France
Product codes and lots: Lot code: 251J00d2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1386-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1386-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-16

Product code NHA

K163634Class IIExternal Hex ImplantsSouthern Implants (Pty), Ltd. / cleared 2017-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)