FDA Medical Device Recalls (openFDA)
ConforMIS, Inc.: Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
- Recall number
- Z-0581-2015
- Recalling firm
- ConforMIS, Inc.
- Product
- Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
- Status
- Terminated
- Initiated
- 2014-11-19
- Posted
- 2014-12-11
- Terminated
- 2015-10-08
- Reason
- Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
- Root cause
- Labeling mix-ups
- Action
- Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
- Quantity
- 1 unit
- Distribution
- Distributed to IN.
- Lot, serial or model codes
- Serial Number: 0340552
- 510(k) numbers
- ["K140423"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3009844603
- Firm city
- Bedford
- 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