Recall Z-1627-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR 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
| Date | Feb 3, 2020 |
| Status | Terminated |
| Reason | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Root cause | Mixed-up of materials/components |
| Action | Conformis Customer Service called three affected customers on February 4, 2020, to ask them to verify tibial tray serial numbers, and confirmed that the three kits in question had the incorrect tibial tray. These affected customers were asked to return the affected product to the firm. Following this action, Conformis Sales Representatives were instructed to verify that all products within their control, including those already placed in hospitals, that were manufactured between September 1, 2019, and February 3, 2020, had tibial tray serial numbers that matched the patient's serial number. N |
| Quantity | 4 |
| Distribution | US Nationwide distribution in the states of LA, NY, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc., May 16, 2018 |