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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - 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, 95mm Material Number: 66-595 - 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, 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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

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

Jan 15, 2021 Infusion Pumps Nationwide View Details →

System INFX-8000F

Canon Medical System, USA

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.

Feb 5, 2021 Other Medical Devices Nationwide View Details →

Thread-like wire marker

Somatex Medical Technologies GMBH

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.

Feb 3, 2021 Other Medical Devices View Details →

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 →

VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

Draeger Medical

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.

Jan 29, 2021 Patient Monitors 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 →

Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910

Thermo Fisher Scientific

Class I - Dangerous

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 chromatogram. The resulting sample would show a Vitamin D-concentration that is an unusual situation for human serum and plasma samples and would indicate a severe Vitamin D deficiency.

Feb 1, 2021 Other Medical Devices 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 →