Recall Z-1591-2024 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
| Date | Apr 17, 2024 (initiated Mar 11, 2024) |
| Status | Open, Classified |
| Reason | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack. |
| Root cause | Process design |
| Action | On March 22, 2024 customers were sent URGENT MEDICAL DEVICE FIELD ACTION letters via email. Customers were provided the following instructions: Conformis is seeking the return of the devices in boxes marked with Lot 508287 or Lot 540827. This is the only lot that was distributed. Our records indicate you are the recipient of one of the affected Lot. If you have not already, please return the device using the provided FEDEX label. Additionally, return page 2 of this letter to acknowledge receipt of this notification. Please read, complete, and sign page 2 of this letter. If you have any questio |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of FL, KS and NH. |
| FDA record | Open on fda.gov |