LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to prod
FDA device recall Z-2884-2011 · posted 2011-07-26 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 232 unit
- Distribution
- Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType=RCL
- Date initiated
- 2011-03-14
- Date posted
- 2011-07-26
- Date terminated
- 2011-07-27
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION (K092341) | Biomet 3i, Inc. | 2009-11-30 |