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

Recall Z-0077-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4

U.S. FDA — Device Enforcement · United States · 2020-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0077-2021
Date of alert
2020-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet 3i, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00844868031185
Reported risk: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
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.

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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.