Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
USBrand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Recalling Firm: United Orthopedic Corp.
Reason for Recall / Hazard
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Product Description & Identification
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Affected Products
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Additional Source Details
| Field | Value |
|---|---|
| City | Kaohsiung |
| Event id | 99025 |
| Address 1 | No. 16 Luke 1st Rd. |
| Address 2 | Luzhu Dist. |
| Code info | Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58 |
| Postal code | N/A |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 3 |
| Reason for recall | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Letter |
| Center classification date | 20260806 |
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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 offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A Check if your household is affected: https://therecallfile.com/recalls/brand-name-u2-total-knee-system-product-name-femoral-offset-bushing-0m/FDA-Z-2897-2026
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