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Terminated

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

FDA Recall Z-2271-2012 · Posted 2012-08-24

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2012-05-31
Date Terminated2013-11-21
Product Quantity611 units

Reason for Recall

Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due to some packages labeled LPCCC1, Hexed Castable Cylinder possibly containing LPCCC2, Non-Hexed Castable Cylinders.

Firm Action

Biomet 3i sent a "MEDICAL DEVICE ADVISORY NOTICE" dated May 31, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this recall.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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