FDA Devices recall · Reported August 12, 2026
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
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
United Orthopedic Corp. recalled Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Mode… - a moderate-severity action.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Mode… was recalled by United Orthopedic Corp. in August 12, 2026. Reason: Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect …. Check the official notice for the remedy. Verify recall #Z-2897-2026 with the FDA Devices before acting.
The recall
United Orthopedic Corp. issued this moderate-severity FDA Devices recall-Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect ….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2897-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2897-2026 |
| Date reported | August 12, 2026 |
| Date initiated | March 19, 2026 |
| Recalling firm | United Orthopedic Corp. |
| Firm location | Kaohsiung |
| Affected scope | 3 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2897-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026