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Terminated

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

FDA Recall Z-2884-2011 · Posted 2011-07-26

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2011-03-14
Date Terminated2011-07-27
Product Quantity232 unit

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092341LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTIONBiomet 3i, Inc. · 2009-11-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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