—#100641

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

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K092341
Affected lot / code info: Model LPCCC2 Lot# 2010101036 and 2010101037.

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

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

Timeline

Recall initiated: 2011-03-14
Posted by FDA: 2011-07-26
Terminated: 2011-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.