Conformis, Inc. Identity Imprint PS Tibial Tray Size 4: Lot 540287 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Catalog Number: TPS-301-T04S, UDI#: M572TPS301T04S011, Lot number 540287
Products Sold
Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Conformis, Inc. is recalling Identity Imprint PS Tibial Tray Size 4: Lot 540287 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 questions please contact myself or another Conformis representative. If you have an urgent question, please call customer service 781 345 9001.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026