iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
- Company
- Conformis, Inc.
- Recall Initiated
- October 16, 2018
- Terminated
- June 29, 2020
- Recall Number
- Z-0731-2019
- Quantity
- 1
- Firm Location
- Billerica, MA
Reason for Recall
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.
Distribution
The products were distributed to the following US states: TN.
Lot / Code Info
Serial Number 0424647
Root Cause
Under Investigation by firm
Action Taken
The customer was contacted via email on 10/16/18.
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