Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 17, 2021
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) recalled CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 … - a moderate-severity action.
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 … 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-1232-2021 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-1232-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1232-2021) was formally reported on March 17, 2021, with the manufacturer initiating the action on January 15, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is listed as the recalling firm, operating out of Marquette, MI. 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.
The documented reason for this recall is: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision Distribution data in the federal record shows the product reached: US Nationwide distribution.. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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
Unknown
Related Recalls
6
3 from same agency
Product description
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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-1232-2021 |
| 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-1232-2021) 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.
Frequently Asked Questions
What product was recalled? ▼
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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).. Recalled by Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.).
Why was this product recalled? ▼
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Moderate. Recall number: Z-1232-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1232-2021) 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.
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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 March 17, 2021. 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 July 2026.