🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
All Recalls
95,025 total recalls in our database
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
OraSure Technologies
🏥 Medical Devices Class I - Dangerous
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 Substrate Reagent (TMB) lot 6679623, should not affect performance.
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
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.
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Medical Components, Inc
🏥 Medical Devices Class I - Dangerous
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 stem because of the incorrect size may not be noted until well into the procedure, after the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
🏥 Medical Devices Class I - Dangerous
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 34mm Material Number: 66-234 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 24m Material Number: 66-124 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - 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).
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
🏥 Medical Devices Class I - Dangerous
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.