FDA Devices recall · Reported November 22, 2017
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collat
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Smith & Nephew, Inc. recalled smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71… - a moderate-severity action.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71… was recalled by Smith & Nephew, Inc. in November 22, 2017. Reason: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.. Check the official notice for the remedy. Verify recall #Z-0092-2018 with the FDA Devices before acting.
The recall
Smith & Nephew, Inc. issued this moderate-severity FDA Devices recall-The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw..
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- November 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0092-2018 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
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Reason for recall
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0092-2018 |
| Date reported | November 22, 2017 |
| Date initiated | September 14, 2017 |
| Recalling firm | Smith & Nephew, Inc. |
| Firm location | Memphis, TN |
| Affected scope | 10 units |
| Distribution | US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand |
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-0092-2018) 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