Drug recall
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage…
FDA recall event 87251 · Class II · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Key facts
| Event ID | 87251 |
|---|---|
| Recall numbers | Z-1204-2021, Z-1205-2021, Z-1206-2021, Z-1207-2021, Z-1208-2021, Z-1209-2021, Z-1210-2021, Z-1211-2021, Z-1212-2021, Z-1213-2021, Z-1214-2021, Z-1215-2021 and 29 more |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Product type | Devices |
| Products | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative…, CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative…, 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…, CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative…, CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative… and 36 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
| Initiation date | Jan 15, 2021 |
| Report date | Mar 17, 2021 |
| City | Marquette |
| State | MI |
| Country | United States |
| FEI number | 1000115331 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: