FDA Medical Device Recalls (openFDA)
Southern Implants, (Pty.) Ltd.: 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.
- Recall number
- Z-1386-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-03-08
- Posted
- not on file
- Terminated
- 2019-09-26
- Reason
- The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
- Root cause
- Process control
- Action
- The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.
- Quantity
- 49 units
- Distribution
- US, South Africa, France
- Lot, serial or model codes
- Lot code: 251J00d2
- 510(k) numbers
- ["K163634"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 3003394627
- Firm city
- Irene
- Firm state
- Gauteng
- Firm country
- South Africa
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28