Z-2316-2020 Class II Terminated
FDA device recall Z-2316-2020 was initiated by Biomet on May 14, 2020 and is designated Class II. Reason for recall: Distributed to the field without having completed design history files or design transfer activities The recall status is terminated (terminated April 8, 2021). Affected quantity: 16 OUS.
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
- 16 OUS
Product Description
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - 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: 356240 (01)00887868134784(17)270717(10)356240