FDA Recall
Terminated
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
Recall: Z-0991-2017
·
Initiated October 31, 2016
Recall
- Recall Number
- Z-0991-2017
- Event Number
- 75969
- Firm
- ConforMIS, Inc.
- FEI Number
- 3009844603
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Software Design Change
- Initiated
- October 31, 2016
- Posted
- January 10, 2017
- Terminated
- January 11, 2017
- Address
- 28 Crosby Dr, Bedford, MA, 01730-1402
Description
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
Reason
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Action
ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit. For questions regarding this recall call 781-345-9001.
Distribution
Distribution to TX only
Quantity
1 unit