RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material recall — FDA Z-1237-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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 product may be contaminated with Burkholderia cepacia
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
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
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 complaints received regarding missing lid magnets which may result in premature battery depletion.
The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port…
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
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
Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained…
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
Browse recent months with enough recall history for useful comparison.