FDA Medical Device Recalls (openFDA)
Conformis, Inc.: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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-1108-2019
- Recalling firm
- Conformis, Inc.
- Product
- iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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
- 2018-12-03
- Posted
- not on file
- Terminated
- 2020-06-26
- Reason
- The kits were prepared with incorrect patient ID labels and may contain incorrect components.
- Root cause
- Labeling mix-ups
- Action
- Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
- Quantity
- 2
- Distribution
- Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
- Lot, serial or model codes
- Serial Numbers 0432428 and 0432212
- 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