Z-2308-2020 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
- 15 OUS
Product Description
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - 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: J3835075 (01)00887868131769(17)260722(10)J3835075