Device product
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Z-0475-2021
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 86615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0475-2021
Official wording
Reason: Incorrect hip components were provided in kits.
Code information: Serial numbers 0469255, 0469255
Distribution pattern: US Distribution in CA.
Derived failure modes
-
Unknown
Incorrect hip components were provided in kits.