Identity Imprint PS Tibial Tray Size 4: Lot 540287 recallZ-1591-2024 · Conformis, Inc. · initiated Mar 11, 2024
Class II Open, Classified All recalls posted in April 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Conformis, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1591-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 11, 2024
- Posted by the FDA
- Apr 17, 2024
- Recalling firm
- Conformis, Inc.
- Quantity
- 3 units
- Product code
- JWH
- FDA submissions
- K210191, K231233
- Distribution
- US Nationwide distribution in the states of FL, KS and NH.
Product description
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Code information (models, lots, serial numbers)
Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Other devices under the same FDA submission
3 devices cleared under K210191, K231233 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Identity Imprint Knee Replacement System TPS000D00201Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Identity Imprint Knee Replacement System TCR000D00201Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Identity Imprint Knee Replacement System TCR301T03S01Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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