Device product
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER 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-0861-2017
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 75761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,371
- Official record key
device-enforcement:Z-0861-2017
Official wording
Reason: A limited number of product pouches may not have been sealed during packaging.
Code information: Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347
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.