FDA Medical Device Recalls (openFDA)
ConforMIS, Inc.: ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
- Recall number
- Z-0658-2017
- Recalling firm
- ConforMIS, Inc.
- Product
- ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
- Status
- Terminated
- Initiated
- 2016-10-18
- Posted
- not on file
- Terminated
- 2016-12-07
- Reason
- Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
- Root cause
- Labeling Change Control
- Action
- ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
- Quantity
- 2 units
- Distribution
- Distributed to the states of CO and NV.
- Lot, serial or model codes
- Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
- 510(k) numbers
- ["K160025"]
- 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