Device product
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Z-0064-2020
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 83760
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0064-2020
Official wording
Reason: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Code information: 0447621
Distribution pattern: Distributed to consignees in MD and NV.
Derived failure modes
-
Unknown
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.