Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 17 of 125
Smith & Nephew, Inc.
Class II Ongoing
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Reason: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGR...
Z-2444-2023 August 30, 2023 Memphis, TN
Boston Scientific Corporation
Class II Ongoing
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Reason: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Z-2441-2023 August 30, 2023 Saint Paul, MN
Smith & Nephew, Inc.
Class II Ongoing
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Reason: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGR...
Z-2443-2023 August 30, 2023 Memphis, TN
Olympus Corporation of the Americas
Class II Ongoing
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) ...
Reason: Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, s...
Z-2413-2023 August 23, 2023 Center Valley, PA
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2308-2023 August 9, 2023 Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAPHY PACK, Model Number: DYNJ65963A; b. ARTHOGRAM TRAY, Model Number: P...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2338-2023 August 9, 2023 Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, ...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2322-2023 August 9, 2023 Northfield, IL
Aesculap Implant Systems LLC
Class II Ongoing
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Reason: Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Z-2146-2023 July 26, 2023 Center Valley, PA
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) I...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2172-2023 July 26, 2023 Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2171-2023 July 26, 2023 Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXT...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2191-2023 July 26, 2023 Northfield, IL
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2123-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2117-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2118-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2120-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2122-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2121-2023 July 19, 2023 Memphis, TN
Medtronic Sofamor Danek USA Inc
Class II Ongoing
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Reason: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted betw...
Z-2119-2023 July 19, 2023 Memphis, TN
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Class II Ongoing
BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 1...
Reason: Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include...
Z-2061-2023 July 12, 2023 GAATON, N/A
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Class II Ongoing
BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:11...
Reason: Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients include...
Z-2060-2023 July 12, 2023 GAATON, N/A
Medtronic Neuromodulation
Class II Ongoing
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Reason: A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total o...
Z-2036-2023 July 5, 2023 Minneapolis, MN
Implant Direct Sybron Manufacturing LLC
Class II Ongoing
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGA...
Reason: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Z-2037-2023 July 5, 2023 Westlake Village, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1804-2023 June 28, 2023 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1746-2023 June 28, 2023 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1742-2023 June 28, 2023 Mounds View, MN