Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 37 of 125
Smith & Nephew, Inc.
Class II Terminated
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder...
Reason: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Z-0933-2021 February 10, 2021 Memphis, TN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE...
Reason: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Z-0927-2021 February 3, 2021 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wire...
Reason: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Z-0926-2021 February 3, 2021 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Reason: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Z-0928-2021 February 3, 2021 Mounds View, MN
Boston Scientific Corporation
Class I Terminated
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Reason: There is potential for fractures which results in the inability to delivery therapy.
Z-0879-2021 January 27, 2021 Saint Paul, MN
Medtronic Neuromodulation
Class II Ongoing
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtron...
Reason: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Z-0860-2021 January 20, 2021 Minneapolis, MN
Boston Scientific Corporation
Class II Terminated
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0778-2021 January 13, 2021 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0775-2021 January 13, 2021 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0773-2021 January 13, 2021 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0776-2021 January 13, 2021 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0777-2021 January 13, 2021 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse...
Reason: The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resu...
Z-0774-2021 January 13, 2021 Marlborough, MA
Biomet, Inc.
Class II Terminated
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: ...
Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Z-0619-2021 December 23, 2020 Warsaw, IN
Biomet, Inc.
Class II Terminated
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Z-0624-2021 December 23, 2020 Warsaw, IN
Medtronic Neuromodulation
Class II Terminated
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease,...
Reason: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Z-0612-2021 December 23, 2020 Minneapolis, MN
Medtronic Heart Valves Division
Class II Terminated
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV ...
Reason: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Z-0560-2021 December 16, 2020 Santa Ana, CA
Medtronic Heart Valves Division
Class II Terminated
Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVO...
Reason: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Z-0559-2021 December 16, 2020 Santa Ana, CA
Medtronic Heart Valves Division
Class II Terminated
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-2...
Reason: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Z-0561-2021 December 16, 2020 Santa Ana, CA
Geistlich Pharma North America, Inc.
Class II Terminated
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
Reason: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i...
Z-0490-2021 December 2, 2020 Princeton, NJ
Advanced Bionics, LLC
Class III Terminated
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na...
Reason: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Z-0486-2021 December 2, 2020 Valencia, CA
Geistlich Pharma North America, Inc.
Class II Terminated
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
Reason: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i...
Z-0492-2021 December 2, 2020 Princeton, NJ
Geistlich Pharma North America, Inc.
Class II Terminated
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
Reason: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly i...
Z-0491-2021 December 2, 2020 Princeton, NJ
Coloplast Manufacturing US, LLC
Class II Terminated
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Reason: Potential increased occurrence of pump fracture over the lifetime of the device.
Z-0488-2021 December 2, 2020 Minneapolis, MN
Advanced Bionics, LLC
Class III Terminated
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na...
Reason: Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Z-0487-2021 December 2, 2020 Valencia, CA
Stryker GmbH
Class II Ongoing
Osteosynthesis Compression Staple EasyClip
Reason: The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
Z-0457-2021 November 25, 2020 Selzach, N/A