Device product
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Z-1382-2017
Product summary
- Event
- Event 76356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28
- Official record key
device-enforcement:Z-1382-2017
Official wording
Reason: Mislabeling. The packaging labeled as left mandible contained a right mandible.
Code information: OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
Distribution pattern: Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Derived failure modes
-
Labeling or packaging
Mislabeling