Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
USBrand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Recalling Firm: United Orthopedic Corp.
Reason for Recall / Hazard
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Product Description & Identification
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Affected Products
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Additional Source Details
| Field | Value |
|---|---|
| City | Kaohsiung |
| Event id | 99026 |
| Address 1 | No. 16 Luke 1st Rd. |
| Address 2 | Luzhu Dist. |
| Code info | Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34 |
| Postal code | N/A |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 2 |
| Reason for recall | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260520 |
| Initial firm notification | Letter |
| Center classification date | 20260805 |
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Overview
- Recalling FirmUnited Orthopedic Corp.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of Texas and Michigan.
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🚨 SAFETY ALERT: United Orthopedic Corp. - Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A Check if your household is affected: https://therecallfile.com/recalls/brand-name-u2-total-knee-system-product-name-psa-box-trial-l-1-6-and-p/FDA-Z-2883-2026
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