Device product
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
Z-1510-2021
Product summary
- Event
- Event 87717
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units US and 193 units OUS. 195 units WW
- Official record key
device-enforcement:Z-1510-2021
Official wording
Reason: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Code information: Lot Number: 50906647
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
Derived failure modes
-
Labeling or packaging
Mislabeled