Conformis iTotal CR G2 Knee Replacement System recallZ-0581-2015 · ConforMIS, Inc. · initiated Nov 19, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConforMIS, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
FDA root cause category: Labeling mix-ups
What the company is doing
Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
Recall details
- Recall number
- Z-0581-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 19, 2014
- Posted by the FDA
- Dec 11, 2014
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 1 unit
- Product code
- JWH
- FDA submissions
- K140423
- Distribution
- Distributed to IN.
Product description
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.
Code information (models, lots, serial numbers)
Serial Number: 0340552
Other devices under the same FDA submission
4 devices cleared under K140423 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Conformis, Inc. · Knee Arthroplasty Implantation System390 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- iTotal® CR iPoly™ Insert Kit RCR010000B03Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- iTotal® CR iPoly™ Insert Kit RCR010080003Conformis, Inc. · Knee Arthroplasty Implantation System1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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