Z-2884-2011

LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be...

Name: Z-2884-2011 LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be...
Creator: Biomet 3i, LLC
Published: 2011-03-14
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2011-03-14 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental... on 2011-03-14. The reason FDA records is "Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package...". 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-2884-2011
Status: Terminated
Initiated: 2011-03-14
Posted: 2011-07-26
Terminated: 2011-07-27
Recalling firm: ZimVie US Corp LLC
Product: LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i 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, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly describe the package contents. Product was distributed in Europe only.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers. The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification. For additional information, please contact Customer Service at 800-342-5454.
Quantity in commerce: 232 unit
Distribution: Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL
Product codes and lots: Model LPCCC2 Lot# 2010101036 and 2010101037.

Product code NHA

K092341Class IILow Profile Abutments - Internal and External ConnectionBiomet 3i, Inc. / cleared 2009-11-30

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)