Device product
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Z-2308-2020
Product summary
- Firm
- Biomet
- Event
- Event 85701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 OUS
- Official record key
device-enforcement:Z-2308-2020
Official wording
Reason: Distributed to the field without having completed design history files or design transfer activities
Code information: Lot Number: J3835075 (01)00887868131769(17)260722(10)J3835075
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