Z-0624-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 25, 2020
- Termination Date
- May 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7428
Product Description
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
Reason for Recall
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Distribution Pattern
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Code Information
Lots 197660 207230 085200 155720