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Biomet recalls A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended f
Recalled June 17, 2020 · FDA recall Z-2309-2020 · Biomet
Hazard
Distributed to the field without having completed design history files or design transfer activities · FDA Class II
Units
15 OUS
Sold at
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.
Description
Distributed to the field without having completed design history files or design transfer activities
Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Manufacturer(s)
Biomet
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →