Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - 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.)
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, 38mm Material Number: 66-238 - 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.)
Class I - Dangerous
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 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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, 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.)
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, 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.)
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.)
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.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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.)
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, 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.)
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, 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.)
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.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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.)
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.)
Class I - Dangerous
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision