Recall Z-1206-2021
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · initiated January 15, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: Batch Number: 328895 328896 328897
Reason for recall
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
FDA-determined cause: Under Investigation by firm
Action taken
Pioneer Surgical Technology, Inc. (DBA RTI Surgical) initiated email notification on 15 January 2021 via the Distributor. End Users notified via Distributor by First Class Mail. Letter states reason for recall, health risk and action to take: Remove from all user sites and inventory locations the CervAlign Anterior Cervical Plates listed in the attached distribution list. Kindly return CervAlign Anterior Cervical Plates RTI Surgical along with the appropriate forms. RTI Surgical is working on corrective actions to prevent these events from reoccurring. We do not know at this time how long this will take to apply these corrective actions, but as soon as we do, we will notify you. If you have any questions or concerns, please contact me at your earliest convenience. RTI Surgical apologizes for any inconvenience this caused Surgalign. Thank you for your cooperation. Contact: Director of Quality Pioneer Surgical (d.b.a. RTI Surgical), 375 River Park Circle, Marquette, MI 49855 U.S.A. (www.rtix.com) P: 763-238-2034 E: jduncan@rtix.com
Details
- Recall number
- Z-1206-2021
- Initiated
- January 15, 2021
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Distribution
- US Nationwide distribution.
- Recalling firm
- RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Marquette, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1204-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1205-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1207-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1208-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1209-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1210-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1211-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1212-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1213-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1214-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 32mm Material Number: 66-232…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1215-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1216-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1217-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1218-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1219-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1220-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1221-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1222-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number:…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1223-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1224-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1225-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1226-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1227-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1228-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1229-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1230-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1231-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1232-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1233-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |
| Z-1234-2021 Class II | CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484…Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in… | 01/15/2021Open, Classified |