Device product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Z-1646-2021
Product summary
- Event
- Event 87696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 305 units
- Official record key
device-enforcement:Z-1646-2021
Official wording
Reason: Products labeled as sterile were distributed, but may not have been sterilized.
Code information: LOT: 2002439, 20051290, 20061420, 20081943
Distribution pattern: US Nationwide distribution in the states MS and KY.
Derived failure modes
-
Unknown
Products labeled as sterile were distributed, but may not have been sterilized.