Z-2271-2012 Class II Terminated
FDA device recall Z-2271-2012 was initiated by Biomet 3I, LLC on May 31, 2012 and is designated Class II. 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… The recall status is terminated (terminated Nov 21, 2013). Affected quantity: 611 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 5, 2012
- Initiation Date
- May 31, 2012
- Termination Date
- Nov 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 611 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
Code Information
Lots: 2010100001, 2010080684, and 2010090191
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2271-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026