Z-2315-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 14, 2020
- Termination Date
- April 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 US and 1 OUS
Product Description
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason for Recall
Distributed to the field without having completed design history files or design transfer activities
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.
Code Information
Lot Number: All lots expiring prior to December 31, 2026