FDA Devices recall · Reported March 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalled CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345… - a moderate-severity action.
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345… was recalled by Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) in March 17, 2021. Reason: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in r…. Check the official notice for the remedy. Verify recall #Z-1221-2021 with the FDA Devices before acting.
The recall
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) issued this moderate-severity FDA Devices recall-Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in r….
- Moderate
- severity level
- Class II
- classification
- March 17, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1221-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. 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
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).
Reason for recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1221-2021 |
| Date reported | March 17, 2021 |
| Date initiated | January 15, 2021 |
| Recalling firm | Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Firm location | Marquette, MI |
| Affected scope | Not disclosed |
| Distribution | US Nationwide distribution. |
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-1221-2021) 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