🏥 Medical Devices Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
All Recalls
95,114 total recalls in our database
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - 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
System INFX-8000C
Canon Medical System, USA
🏥 Medical Devices Class I - Dangerous
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - 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, 3Level, 54mm Material Number: 66-354 - 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, 3Level, 51mm Material Number: 66-351 - 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
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - 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
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - 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 100cm EBU 3.75 Model Number: LA6EBU375
Medtronic Vascular
🏥 Medical Devices Class I - Dangerous
Sterility may be compromised due to an unsealed pouch
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - 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, 4Level, 72mm Material Number: 66-472 - 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
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - 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, 4Level, 80mm Material Number: 66-480 - 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
System INFX-8000F
Canon Medical System, USA
🏥 Medical Devices Class I - Dangerous
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Thread-like wire marker
Somatex Medical Technologies GMBH
🏥 Medical Devices Class I - Dangerous
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 removed during the procedure and stays inside the patient's body.