RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material recall — FDA Z-1239-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Complete FDA and NHTSA recall records dated in March 2021.
These records include useful source details for the selected month.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not…
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
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
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
Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the…
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.