FDA-Device2020-06-17Class II
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Biomet
Hazard
Distributed to the field without having completed design history files or design transfer activities
Sold states
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.
Affected count
1 OUS
Manufactured in
6303 Blue Lagoon Dr Ste 100, N/A, Miami, FL, United States
Products
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2020Don't want to check this manually?
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