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.
FDA Recall Z-1386-2018 · Posted None
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Recalling FirmSouthern Implants, (Pty.) Ltd.
Recall StatusTerminated
Product CodeNHA
Date Initiated2018-03-08
Date Terminated2019-09-26
Product Quantity49 units
Reason for Recall
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Firm Action
The firm initiated their recall by email on 03/08/2018. The firm requested return of the product.
Root Cause
Process control
Distribution Pattern
US, South Africa, France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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