Z-2271-2012Class II

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF...

Name: Z-2271-2012 Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF...
Creator: Biomet 3i, LLC
Published: 2012-05-31
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2012-05-31 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable... on 2012-05-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2271-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-31
Posted: 2012-08-24
Terminated: 2013-11-21
Recalling firm: ZimVie US Corp LLC
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.
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 611 units
Distribution: Worldwide Distribution-Distributed in the USA and the countries to Spain, France, Germany, Switzerland, and Australia.
Product codes and lots: Lots: 2010100001, 2010080684, and 2010090191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2271-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-24

Product code NHA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)