Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
USBrand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
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: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Affected Products
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
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 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53 |
| 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: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No Check if your household is affected: https://therecallfile.com/recalls/brand-name-u2-total-knee-system-product-name-femoral-valgus-offset-ada/FDA-Z-2886-2026
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