Device product
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) 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-0832-2017
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 75761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 431
- Official record key
device-enforcement:Z-0832-2017
Official wording
Reason: A limited number of product pouches may not have been sealed during packaging.
Code information: Part # ILPAC4330 Lot # 2015111372, 201611713, 2016020101, and 2016050131
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.