Recall Z-2884-2011 ยท NHA Abutment, Implant, Dental, Endosseous
Biomet 3i, LLC
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
| Date | Jul 26, 2011 (initiated Mar 14, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 232 unit |
| Distribution | Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION Biomet 3i, Inc., Nov 30, 2009 |