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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Event Detail

Event ID 68331
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-22
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US (nationwide)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker 3.0mm x 3.8mm Neuro Drill Less 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. Part Number 5820-107-430S1, Lot Number 14003017,14005017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 916 Z-1780-2014
Stryker 5.0mm Barrel 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. Part Number 5820-017-050S1, Lot Number 14015017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 1 Z-1779-2014
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. Part Number 5820-107-530, Lot Number 13332017, 13332027, 13332037, 13333017, 13333027, 13334017, 13334027, 13336017, 13336027, 13346017, 13347017, 13347027, 13347037, 14017017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 6481 Z-1778-2014
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. Part Number 5820-107-430, Lot Number 13350017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 497 Z-1777-2014
Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch 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. Part Number 5820-107-40, Lot Number 13339017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 188 Z-1776-2014
Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch 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. Part Number 5820-107-30, Lot Number 13351017, 14007017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 802 Z-1775-2014
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch 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. Part Number 5820-107-25, Lot Number 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 41 Z-1774-2014
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. Part Number 5820-103-15, Lot Number 14004017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 246 Z-1773-2014
Stryker 1.3mm 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. Part Number 5820-103-13, Lot Number 14004017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 176 Z-1772-2014
Lindemann Drill Short, 1.6mm 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. Part Number 5820-102-16, Lot Number 14006017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 12 Z-1771-2014
Stryker 6.0mm 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. Part Number 5820-30-60, Lot Number 13353017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 59 Z-1770-2014
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. Part Number 5820-30-50, Lot Number 13347017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 71 Z-1769-2014
Stryker 5.0mm Barrel Bur Sterile Part Number 5820-17-50, Lot Number 13345017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 15 Z-1768-2014
Stryker 6.0mm 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. Part Number 5820-15-60, Lot Number 14002017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 65 Z-1767-2014
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. Part Number 5820-15-50, Lot Number 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 144 Z-1766-2014
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. Part Number 5820-10-920, Lot Number 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 4 Z-1765-2014
Stryker 6.0mm 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. Part Number 5820-10-660, Lot Number 13352017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 107 Z-1764-2014
Stryker 5.0mm 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. Part Number 5820-10-650, Lot Number 14005027 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 4 Z-1763-2014
Stryker 3.5mm 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. Part Number 5820-10-635, Lot Numbers 13354017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 39 Z-1762-2014
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. Part Number 5820-10-320, Lot Numbers 14009017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 6 Z-1761-2014
Stryker 6.0mm 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. Part Number 5820-10-260, Lot Numbers 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 301 Z-1760-2014
Stryker 5.5mm 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. Part Number 5820-10-255, Lot Numbers 13354017, 14013017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 84 Z-1759-2014
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. Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 1537 Z-1758-2014
Stryker 4.5mm 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. Part Number 5820-10-245, Lot Number 13350017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 62 Z-1757-2014
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. Part Number 5820-10-230, Lot Number 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 285 Z-1756-2014
Stryker 5.5mm Round Fluted Bur Soft Touch 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. Part Number 5820-10-155, Lot Number 13346017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 99 Z-1755-2014
Stryker 3.0mm Round Fluted Bur Soft Touch 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. Part Number 5820-10-130, Lot Numbers 13346017, 13346027 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 609 Z-1754-2014
Stryker 6.0mm 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. Part Number 5820-10-60, Lot Numbers 13343017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 256 Z-1753-2014
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. Part Number 5820-10-40, Lot Numbers 13344017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 281 Z-1752-2014
Stryker 2.0mm 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. Part Number 5820-10-20, Lot Numbers 13347017,14010017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 252 Z-1751-2014
Stryker 1.0mm 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. Part Number 5820-10-10, Lot Number 14005017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 72 Z-1750-2014
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. Part Number 5820-10-5, Lot Number 13354017 Class II There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments. 27 Z-1749-2014
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