Device product
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.
Z-0624-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7428
- Official record key
device-enforcement:Z-0624-2021
Official wording
Reason: 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.
Code information: Lots 197660 207230 085200 155720
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
Derived failure modes
-
Sterility assurance
loss of sterility