Device product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Z-0731-2019
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 81723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0731-2019
Official wording
Reason: The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Code information: Serial Number 0424647
Distribution pattern: The products were distributed to the following US states: TN.
Derived failure modes
-
Unknown
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.