| Class 2 Device Recall CervAlign Anterior Cervical Plate System |  |
Date Initiated by Firm | January 15, 2021 |
Create Date | March 11, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1204-2021 |
Recall Event ID |
87251 |
Product Classification |
Appliance, fixation, spinal intervertebral body - Product Code KWQ
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Product | 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 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). |
Code Information |
Batch Number: 328891, 328892 |
Recalling Firm/ Manufacturer |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) 375 River Park Cir Marquette MI 49855-1781
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For Additional Information Contact | SAME 906-226-9909 |
Manufacturer Reason for Recall | Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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 |
Quantity in Commerce | 65 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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