Device product
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Z-1623-2016
Product summary
- Event
- Event 73856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1623-2016
Official wording
Reason: Incorrect component used to manufacture distal femoral replacement.
Code information: Device Identifier: PIN 19960, Lot: 19960
Distribution pattern: US distribution to OH.
Derived failure modes
-
Unknown
Incorrect component used to manufacture distal femoral replacement.