iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY 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 a unicondylar, patellofemoral or bicompartmental prosthesis.
- Company
- Conformis, Inc.
- Recall Initiated
- February 3, 2020
- Terminated
- December 2, 2020
- Recall Number
- Z-1628-2020
- Quantity
- 2
- Firm Location
- Billerica, MA
Reason for Recall
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Distribution
US Nationwide distribution in the states of LA, NY, TN.
Lot / Code Info
0460018 0460118
Root Cause
Mixed-up of materials/components
Action Taken
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. No additional affected product was found in the field.