Device product
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Z-2070-2017
Product summary
- Event
- Event 76868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2070-2017
Official wording
Reason: Missing Dome Pack accessory.
Code information: Lot Number: 7377332
Distribution pattern: US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Derived failure modes
-
Unknown
Missing Dome Pack accessory.