Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1386-2018 — 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.

U.S. FDA — Device Enforcement · South Africa · 2018-03-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1386-2018
Date of alert: 2018-03-08
Country / jurisdiction: South Africa
Risk level: Class II
Risk type: recall
Brand: Southern Implants, (Pty.) Ltd.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1386-2018 — 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.

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