Device product

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

Z-2318-2020

May 14, 2020

Class II

Product summary

Firm: Biomet
Event: Event 85701
Status: Terminated
Classification: Class II
Quantity: 1 US and 1 OUS
Official record key: device-enforcement:Z-2318-2020

Official wording

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

Code information: Lot Number: 356280 (01)00887868134838(17)270716(10)356280; RM256H (01)00887868134838(17)260304(10)RM256H

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