USTAR II Knee System Hinge Box Trial Recall
United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a manufacturing defect that could affect surgical outcomes, but no injuries have been reported yet.
Plain-English summary
United Orthopedic Corp. is recalling its USTAR II Knee System Hinge Box Trial, left and right, sizes #1-6. These are reusable knee femur prosthesis trials used during orthopedic surgery.
The recall is due to an incomplete process of the component screw by a subcontractor, which prevents the properly assembling of the stem trial. This manufacturing defect could affect the device's ability to function correctly during surgery.
The products were distributed nationwide in Texas and Michigan. Patients and surgeons should return the affected devices to United Orthopedic Corp. for replacement or refund. Healthcare facilities should not use the affected devices until they have been returned.
The recalled product
- Product
- Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
- Manufacturer
- United Orthopedic Corp.
- 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 (20)
- Product Number
- UDI-DI Code
- Lot Code: Product number 9325-5711
- UDI-DI 04719886907032
- Lot number 25FB41 Product number 9325-5712
- UDI-DI 04719886907049
- Lot number 25FB42 Product number 9325-5713
- UDI-DI 04719886907056
- Lot number 25FB43 Product number 9325-5714
- UDI-DI 04719886907063
- Lot number 25FB44 Product number 9325-5715
- UDI-DI 04719886907070
- Lot number 25FB45 Product number 9325-5716
- UDI-DI 04719886907087
- Lot number 25FB46 Product number 9325-5721
- UDI-DI 04719886907094
- Lot number 25FB35 Product number 9325-5722
- UDI-DI 04719886907100
- Lot number 25FB36 Product number 9325-5723
- UDI-DI 04719886907117
Distribution
Part of a larger recall action
This product is one of 4 recalled by United Orthopedic Corp. 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.
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