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

Recall Z-1387-2020 — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

U.S. FDA — Device Enforcement · United States · 2020-01-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1387-2020
Date of alert
2020-01-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet 3i, LLC
Product category
device
Product type
Devices
Reported risk: Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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