Conformis, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1591-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Product Classification:

Class II

Date Initiated: March 11, 2024

Date Posted: April 24, 2024

Recall Number: Z-1591-2024

Event ID: 94288

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 3 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated