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

Recall Z-0857-2017 — BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation

U.S. FDA — Device Enforcement · United States · 2016-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0857-2017
Date of alert
2016-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet 3i, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2015112084
Reported risk: A limited number of product pouches may not have been sealed during packaging.
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.