Device product
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW 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-0863-2017
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 75761
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,633
- Official record key
device-enforcement:Z-0863-2017
Official wording
Reason: A limited number of product pouches may not have been sealed during packaging.
Code information: Part # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635, 2016042030, and 2016042036
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.