CLASS II ONGOING Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
CervAlign Anterior Cervical Plate System-Cervalign recalled
RTI Surgical, Inc. ( is recalling CervAlign Anterior Cervical Plate System-Cervalign, 1 Level Material Number: 66-114, distributed nationwide in the US. The recall was initiated on 15 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1206-2021
- FDA event ID
- 87251
- Recalling firm
- RTI Surgical, Inc. (, Marquette, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jan 2021
- FDA classified
- 11 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 15 Jan 2021 | Recall initiated by company | |
| 11 Mar 2021 | Classified by FDA | +55 days |
| 17 Mar 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Product as listed by the FDA
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - 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).
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is CervAlign Anterior Cervical Plate System-Cervalign, 1 Level Material Number: 66-114 recalled?
Yes. RTI Surgical, Inc. ( recalled CervAlign Anterior Cervical Plate System-Cervalign, 1 Level Material Number: 66-114 on 15 Jan 2021. The recall is Class II and its status is Ongoing. Recall number Z-1206-2021.
Why was it recalled?
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Which lots are affected?
Batch Number: 328895 328896 328897
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RTI Surgical, Inc. (
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
| Device | CLASS II | CervAlign Anterior Cervical Plate System-Cervalign recalled | RTI Surgical, Inc. ( | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |