RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material recall — FDA Z-1244-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Overview of recall records associated with RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), including dates, categories and classifications where available.
Classification mix: Class II: 44.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
The Streamline Navigation System taps have experienced binding with other devices.
The Streamline Navigation System taps have experienced binding with other devices.
This page summarizes recall records in which the official source identifies RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.