Device product
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
Z-0625-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7428
- Official record key
device-enforcement:Z-0625-2021
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: Lot numbers 373200 168810 450100 168540 450090
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