Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error
Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.
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, but the source text describes a labeling error and misdelivery without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Conformis, Inc. is recalling two units of the iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101 (ITOTAL PS IPOLY IMPLANT KIT LEFT). The recall is due to a labeling error where a limited number of tibial trays were labeled with an incorrect serial number.
The affected products were distributed nationwide in the United States, specifically in the states of Louisiana, New York, and Tennessee. The incorrect labeling resulted in the trays being delivered to the wrong customer accounts.
Healthcare providers and patients who have received these specific implant kits should contact Conformis, Inc. for further instructions. The recall is limited to the two units identified with the incorrect serial numbers.
The recalled product
- Product
- iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) 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 sol
- Manufacturer
- Conformis, Inc.
- Hazard
- Affected units
- 2
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)
- 0460018 0460118
Distribution
Part of a larger recall action
This product is one of 2 recalled by Conformis, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02