FDA Medical Device Recalls (openFDA)
Conformis, Inc.: iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
- Recall number
- Z-0672-2020
- Recalling firm
- Conformis, Inc.
- Product
- iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
- Status
- Terminated
- Initiated
- 2019-10-25
- Posted
- not on file
- Terminated
- 2020-05-20
- Reason
- Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
- Root cause
- Under Investigation by firm
- Action
- Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of GA.
- Lot, serial or model codes
- Serial Number: 0450585
- 510(k) numbers
- ["K180906"]
- 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