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Implants & Prosthetics

🏥 Medical Devices • 4,540 recalls

Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu, UCR, and NewPort Systems, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

SeaSpine

Class I - Dangerous

Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use.

May 21, 2014 Implants & Prosthetics View Details →

DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.

Biomet

Class I - Dangerous

Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.

May 15, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →

Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

Stryker Instruments Div. of Stryker

Class I - Dangerous

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

May 22, 2014 Implants & Prosthetics Nationwide View Details →
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