Conformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers
ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential fit issue with the device components, which is a moderate risk without reported injuries.
Plain-English summary
ConforMIS, Inc. is recalling one unit of the Conformis iTotal CR G2 Knee Replacement System, catalog/model number M57250600010. The device is intended for use as a total knee replacement in patients with knee joint pain and disability.
The recall was initiated because the tibial inserts packaged in the tray have an incorrect serial number. This discrepancy may result in the inserts not fitting properly during the procedure. The affected unit, serial number 0340552, was distributed to Indiana.
Consumers and healthcare providers should stop using the affected product and contact ConforMIS, Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: 0340552
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · ConforMIS, Inc.
See all →- HighConformis Restor3d Cordera Hip Acetabular Liner Mislabeled
FDA (Devices) · 2025-04-23
- HighConformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
FDA (Devices) · 2024-04-24
- HighHip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm
FDA (Devices) · 2023-08-23
- HighiTotal Identity Impactor Handle surgical screws may loosen during procedures
FDA (Devices) · 2023-02-22
- HighiTotal Identity Knee Replacement System—incorrect tibial base plate packaged
FDA (Devices) · 2022-04-20
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02