Device product
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Z-2306-2020
Product summary
- Firm
- Biomet
- Event
- Event 85701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 OUS
- Official record key
device-enforcement:Z-2306-2020
Official wording
Reason: Distributed to the field without having completed design history files or design transfer activities
Code information: Lot Number: 3286A (01)00887868135033(10)3286A
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