74 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
FDA Enforcement
Class II
·Terminated·Zimmer Gmbh·May 24, 2017
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
FDA Recall
Terminated
·Product code HTT·May 11, 2017
CBS micro, countersink, cannulated, AO, Item Number 503004541
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS high, countersink, cannulated, AO, Item Number ST503004542
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS micro, countersink, cannulated, AO, Item Number ST503004541
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWX·April 8, 2019
CBS high, countersink, cannulated, AO, Item Number 503004542
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS high, countersink, cannulated, round-shaft, Item Number 503004342
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·August 30, 2017
CBS micro, countersink, cannulated, AO, Item Number ST503004541
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS high, countersink, cannulated, AO, Item Number ST503004542
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS high, countersink, cannulated, AO, Item Number 503004542
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
CBS micro, countersink, cannulated, AO, Item Number 503004541
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
FDA Recall
Terminated
·MAQUET Inc.·Product code BSZ·July 10, 2007
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·May 29, 2019