Device product
Porcine Anorganic Bone Mineral 4.0cc
Z-0752-2019
Product summary
- Event
- Event 81626
- Status
- Terminated
- Classification
- Class III
- Quantity
- 136 units
- Official record key
device-enforcement:Z-0752-2019
Official wording
Reason: There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Code information: UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021
Distribution pattern: FL, TX
Derived failure modes
-
Labeling or packaging
mislabeled