FDA Medical Device Recalls (openFDA)
Conformis, Inc.: Identity Imprint PS Tibial Tray Size 4: Lot 540287
- Recall number
- Z-1591-2024
- Recalling firm
- Conformis, Inc.
- Product
- Identity Imprint PS Tibial Tray Size 4: Lot 540287
- Status
- Open, Classified
- Initiated
- 2024-03-11
- Posted
- 2024-04-17
- Terminated
- not on file
- 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 questions please contact myself or another Conformis representative. If you have an urgent question, please call customer service 781 345 9001.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of FL, KS and NH.
- Lot, serial or model codes
- Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
- 510(k) numbers
- ["K210191","K231233"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3009844603
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28