FDA Devices recall · Reported March 18, 2020
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured i
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the r…
Medicrea International recalled Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B3600454… - a moderate-severity action.
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B3600454… was recalled by Medicrea International in March 18, 2020. Reason: An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengagin…. Check the official notice for the remedy. Verify recall #Z-1472-2020 with the FDA Devices before acting.
The recall
Medicrea International issued this moderate-severity FDA Devices recall-An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengagin….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- March 18, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1472-2020 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
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.
Reason for recall
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1472-2020 |
| Date reported | March 18, 2020 |
| Date initiated | January 28, 2020 |
| Recalling firm | Medicrea International |
| Firm location | Rillieux La Pape |
| Affected scope | 3529 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, FL, GA, LA, OH, and RI. International distribution to Greece and Portugal. |
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-1472-2020) 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