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Infusion Pumps

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

OraSure Technologies

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.

Feb 5, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 14mm Material Number: 66-114 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Physio-Control

Class I - Dangerous

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Jan 14, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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.)

Class I - Dangerous

Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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