Device product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Z-2314-2020
Product summary
- Firm
- Biomet
- Event
- Event 85701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 OUS
- Official record key
device-enforcement:Z-2314-2020
Official wording
Reason: Distributed to the field without having completed design history files or design transfer activities
Code information: Lot Number: 452448 (01)00887868151354(10)452448 462794 (01)00887868151354(10)462794
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