71 results
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64ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAFE-MATE
FDA UDI
CASE-MATE, INC.·00846127199377·
ANGLED REAMER SLEEVE, 20°
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·May 21, 2024
28MM +2 LAT BASEPLATE, MODULAR
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code PHX·April 4, 2024
NANOGRIP, NANOSCOPE OPTICS HANDLE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code NBH·June 19, 2024
PIN SET, UNIVERS II/ ECLIPSE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MDM·April 24, 2024
DYNANITE¿ STAPLE DRL BT, CAL, 1.6, REUSE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HTW·April 23, 2024
SCORPION-MULTIFIRE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 17, 2024
ANGLED REAMER, DRIVE SHAFT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 14, 2024
FASTPASS SCORPION, SL-MF
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·May 30, 2024
FASTPASS SCORPION, SL-MF
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·June 14, 2024
FASTPASS SCORPION, SL-MF
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 24, 2024
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code HWT·April 1, 2011
YUKON OCT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION·Product code LXH·March 23, 2018
FASTPASS SCORPION
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code LXH·April 30, 2024
PERC INSERT KIT FOR 3.0 MM KNOTLESS ST
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MDM·June 18, 2024
DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MDM·April 25, 2024
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code HWT·April 1, 2011
12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code HWT·April 1, 2011
12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code HWT·April 1, 2011
00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code HWT·April 1, 2011