Device product
A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Z-2310-2020
Product summary
- Firm
- Biomet
- Event
- Event 85701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 OUS
- Official record key
device-enforcement:Z-2310-2020
Official wording
Reason: Distributed to the field without having completed design history files or design transfer activities
Code information: Lot Number: RM540H (01)00887868132490(17)260623(10)RM540H
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Derived failure modes
-
Unknown
Distributed to the field without having completed design history files or design transfer activities