Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 18, 2018
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
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, LARGE SET SCREW, REF 79-2002 - a moderate-severity action.
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 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-1364-2018 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
- 188 units
- affected scope
- Class II
- classification
- April 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1364-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1364-2018) was formally reported on April 18, 2018, with the manufacturer initiating the action on February 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthofix, Inc is listed as the recalling firm, operating out of Lewisville, TX. Federal records list the affected scope as 188 units.
The documented reason for this recall is: 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. Throug… Distribution data in the federal record shows the product reached: US. Distribution scope 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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.
Affected scope
188 units
Related Recalls
6
6 from same agency
Product description
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
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-1364-2018 |
| Date reported | April 18, 2018 |
| Date initiated | February 23, 2018 |
| Recalling firm | Orthofix, Inc |
| Firm location | Lewisville, TX |
| Affected scope | 188 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-1364-2018) 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.
Frequently Asked Questions
What product was recalled? ▼
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002. Recalled by Orthofix, Inc. Units affected: 188 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1364-2018.
Where was the recalled product distributed? ▼
Distribution: US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1364-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.