Device product
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Z-0862-2017
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 75761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 191
- Official record key
device-enforcement:Z-0862-2017
Official wording
Reason: A limited number of product pouches may not have been sealed during packaging.
Code information: Part # LPCTIC2 Lots # 2015110366, 2015110389, 2015110450, 2015110451, 2015110452, 2016021488, 2016021489, 2016021490, and 2016040888
Distribution pattern: Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Derived failure modes
-
Unknown
A limited number of product pouches may not have been sealed during packaging.