CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Southern Implants recalled
Southern Implants, (Pty.) is recalling Southern Implants. The recall was initiated on 8 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1386-2018
- FDA event ID
- 79653
- Recalling firm
- Southern Implants, (Pty.), Irene, Gauteng
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2018
- FDA classified
- 16 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Mar 2018 | Recall initiated by company | |
| 16 Apr 2018 | Classified by FDA | +39 days |
| 25 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Product as listed by the FDA
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.
Where it was distributed
US, South Africa, France
Questions about this recall
Is Southern Implants recalled?
Yes. Southern Implants, (Pty.) recalled Southern Implants on 8 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1386-2018.
Why was it recalled?
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Which lots are affected?
Lot code: 251J00d2
Where was it sold?
US, South Africa, France
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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