—#111086

Product

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 product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
Affected lot / code info: Lots: 2010100001, 2010080684, and 2010090191

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

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

Timeline

Recall initiated: 2012-05-31
Posted by FDA: 2012-08-24
Terminated: 2013-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.