RTI Surgical CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material recall — FDA Z-1215-2021
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Complete FDA and NHTSA recall records dated in 2021, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
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
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 software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample…
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
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
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.