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Recall Observatory FDA recall evidence

Device product

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

Z-2323-2020

May 14, 2020

Class II

Product summary

Firm
Biomet
Event
Event 85701
Status
Terminated
Classification
Class II
Quantity
1 OUS
Official record key
device-enforcement:Z-2323-2020

Official wording

Reason: Distributed to the field without having completed design history files or design transfer activities

Code information: Lot Number: 408920 (01)00887868134883(17)270627(10)408920

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

    reason.no_named_rule · v1.0.0

    Distributed to the field without having completed design history files or design transfer activities