United Orthopedic Recalls U2 Total Knee System Tibial Inserts Due to Labeling Mismatch
United Orthopedic Corporation is recalling 69 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.
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 source text identifies the issue as a labeling mismatch without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
United Orthopedic Corporation is recalling 69 pieces of the U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick (Catalogue number 2303-3032). The recall was initiated after the company received a customer complaint report from a distributor on October 31, 2017, stating that the contents of the package did not match the product labeling.
The affected lot number is 17B621AX. The devices were distributed worldwide, including in the United States, UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea, and South Africa.
The U2 Total Knee System is indicated for knee arthroplasty in skeletally mature patients with severe knee pain and disability. Consumers and healthcare providers should stop using the affected devices and contact United Orthopedic Corporation for further instructions.
The recalled product
- Product
- U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and
- Manufacturer
- United Orthopedic Corporation
- Hazard
- Affected units
- 69
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)
- Lot number 17B621AX
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by United Orthopedic Corporation 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 · United Orthopedic Corporation
See all →- HighUSTAR II Knee System implants recalled for potential stem misalignment
FDA (Devices) · 2024-03-06
- HighHip Implant System Recalled for Potential Incorrect Stem Orientation
FDA (Devices) · 2024-03-06
- HighOrthopedic knee implant recall due to potential stem misalignment
FDA (Devices) · 2024-03-06
- ModerateUnited Orthopedic Recalls U2 Total Knee System Tibial Inserts
FDA (Devices) · 2018-03-28
- HighUOC Femoral Driver Recalled Due to Locking Lever Pin Breakage Risk
FDA (Devices) · 2017-04-05
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