RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Recall 87251
Description: CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Recall 87251 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1222-2021 |
| Event ID | 87251 |
| Event Description | CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - 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). |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Recall Reason | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
| Device Classification | 20210317 |
| Device Code Info | Batch Number: 333019 333020 338839 341491 346885 351526 354405 359842 359843 363443 364532 369362 370404 377837 379929 385416 |
| Center Classification Date | 20210311 |
| Recall Initiation Date | 20210115 |
| Recalling Firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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