Device product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Z-1591-2024
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 94288
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1591-2024
Official wording
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.
Code information: Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Distribution pattern: US Nationwide distribution in the states of FL, KS and NH.
Derived failure modes
-
Unknown
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.