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

Recall Z-2037-2023 — LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

U.S. FDA — Device Enforcement · United States · 2023-05-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2037-2023
Date of alert
2023-05-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Implant Direct Sybron Manufacturing LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10841307123002
Reported risk: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.