Stryker Instruments Div. of Stryker Corporation - Stryker 2.0mm Zyphr Elite Round Fluted Bur - Class 2 Recall
Stryker 2.0mm Zyphr Elite 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 5.0mm Egg Bur - Class 2 Recall
Stryker 5.0mm Egg 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 2.0mm Tapered Round Elite Bur - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - Stryker 0.5mm Round Fluted Bur - Class 2 Recall
Stryker 0.5mm 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Cochlear Americas Inc. - Cochlear Baha Soft tissue gauge - Class 2 Recall
Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2014 Category: Medical Equipment Source Type: alerts
Siemens Hearing Instruments, Inc - Siemens Hearing Instruments Inc. - Class 2 Recall
Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 19, 2014 Category: Medical Equipment Source Type: alerts
Envoy Medical Corporation - Esteem Programmers - Class 2 Recall
Esteem Programmers part of the Esteem Totally Implantable Hearing SystemWorldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY. This correction applies to the Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. The ISA and Commander are software packages that run on a laptop personal computer. A laptop can be configured to carry both or either one of the ISA and Commander functionality with separate boot records for each application. In the operative suite, the ISA is used to support implants. All ISA units will also carr...
Source: Medical Device Recalls - January 31, 2013 Category: Medical Equipment Source Type: alerts
