Biomet 3i, LLC: Medical Device Recall in 2012 - (Recall #: Z-2271-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 31, 2012

Date Posted: September 5, 2012

Recall Number: Z-2271-2012

Event ID: 62578

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.

Status: Terminated

Product Quantity: 611 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated