Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 46 of 125
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 10051...
Reason: The devices may be missing the implant coil.
Z-1398-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451...
Reason: The devices may be missing the implant coil.
Z-1399-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HC...
Reason: The devices may be missing the implant coil.
Z-1395-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V,...
Reason: The devices may be missing the implant coil.
Z-1405-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA,...
Reason: The devices may be missing the implant coil.
Z-1403-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 10061...
Reason: The devices may be missing the implant coil.
Z-1404-2020 March 4, 2020 Aliso Viejo, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 10...
Reason: The devices may be missing the implant coil.
Z-1393-2020 March 4, 2020 Aliso Viejo, CA
St Jude Medical, Cardiac Rhythm Management Division
Class II Terminated
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (0541...
Reason: Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients ca...
Z-1351-2020 March 4, 2020 Sylmar, CA
Microvention, Inc.
Class II Terminated
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620...
Reason: The devices may be missing the implant coil.
Z-1394-2020 March 4, 2020 Aliso Viejo, CA
Exactech, Inc.
Class II Ongoing
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and ...
Reason: These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm...
Z-1364-2020 March 4, 2020 Gainesville, FL
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1138-2020 February 26, 2020 Temecula, CA
Nobel Biocare Usa Llc
Class II Terminated
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1315-2020 February 26, 2020 Yorba Linda, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1128-2020 February 26, 2020 Temecula, CA
Advanced Bionics, LLC
Class III Terminated
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Reason: Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals ...
Z-1259-2020 February 26, 2020 Valencia, CA
Nobel Biocare Usa Llc
Class II Terminated
Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal con...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1321-2020 February 26, 2020 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implan...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1325-2020 February 26, 2020 Yorba Linda, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1139-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1129-2020 February 26, 2020 Temecula, CA
Nobel Biocare Usa Llc
Class II Terminated
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1302-2020 February 26, 2020 Yorba Linda, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1130-2020 February 26, 2020 Temecula, CA
Nobel Biocare Usa Llc
Class II Terminated
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal ...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1319-2020 February 26, 2020 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1323-2020 February 26, 2020 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1309-2020 February 26, 2020 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1313-2020 February 26, 2020 Yorba Linda, CA
Nobel Biocare Usa Llc
Class II Terminated
Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1312-2020 February 26, 2020 Yorba Linda, CA