FDA Devices recall · Reported April 18, 2018
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affec…
Orthofix, Inc recalled ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 - a moderate-severity action.
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 was recalled by Orthofix, Inc in April 18, 2018. Reason: Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected…. Check the official notice for the remedy. Verify recall #Z-1363-2018 with the FDA Devices before acting.
The recall
Orthofix, Inc issued this moderate-severity FDA Devices recall-Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected….
- Moderate
- severity level
- 397 units
- affected scope
- Class II
- classification
- April 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1363-2018 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
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Reason for recall
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a result, it is possible that (1) the set screw drive feature will not accept the Set Screw Driver (PN: 79-1006) or (2) the driver may get wedged in the corners of the drive feature (false bottom) which may lead to a stripped set screw.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1363-2018 |
| Date reported | April 18, 2018 |
| Date initiated | February 23, 2018 |
| Recalling firm | Orthofix, Inc |
| Firm location | Lewisville, TX |
| Affected scope | 397 units |
| Distribution | US |
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-1363-2018) 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
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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