Device 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.
Z-2271-2012
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 62578
- Status
- Terminated
- Classification
- Class II
- Quantity
- 611 units
- Official record key
device-enforcement:Z-2271-2012
Official wording
Reason: 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.
Code information: Lots: 2010100001, 2010080684, and 2010090191
Distribution pattern: Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
Derived failure modes
-
Unknown
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.