Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 34 of 125
Exactech, Inc.
Class II Ongoing
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation GXL Liner, +5mm Lateralized, G00, 22mm ID. Orthopedic hip implant component.
Reason: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2125-2021 July 28, 2021 Gainesville, FL
Exactech, Inc.
Class II Ongoing
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
Reason: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2127-2021 July 28, 2021 Gainesville, FL
Heartware, Inc.
Class II Ongoing
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac T...
Reason: The pump has an impeller with a shroud height that did not meet the lower control limit.
Z-2072-2021 July 21, 2021 Miami Lakes, FL
IMPLANTCAST GMBH
Class II Terminated
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200...
Reason: A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A ...
Z-2050-2021 July 21, 2021 Buxtehude
Exactech, Inc.
Class II Completed
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat...
Reason: The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Z-1977-2021 July 7, 2021 Gainesville, FL
Wishbone Medical, Inc.
Class II Terminated
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
Reason: Nonconformities were discovered to the engineering specifications for implant plates and screws.
Z-1794-2021 June 16, 2021 Warsaw, IN
Signature Orthopedics Pty Limited
Class II Terminated
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Reason: Product mislabeled, with the incorrect product inside the package.
Z-1694-2021 June 9, 2021 Lane Cove West
K2M, Inc
Class II Terminated
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comp...
Reason: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Z-1696-2021 June 9, 2021 Leesburg, VA
K2M, Inc
Class II Terminated
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compri...
Reason: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Z-1695-2021 June 9, 2021 Leesburg, VA
K2M, Inc
Class II Terminated
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comp...
Reason: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Z-1697-2021 June 9, 2021 Leesburg, VA
Nobel Biocare Procera LLC
Class II Terminated
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s ...
Reason: Not manufactured to specification
Z-1678-2021 June 2, 2021 Mahwah, NJ
Nobel Biocare Procera LLC
Class II Terminated
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s...
Reason: Not manufactured to specification
Z-1680-2021 June 2, 2021 Mahwah, NJ
Nobel Biocare Procera LLC
Class II Terminated
NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s...
Reason: Not manufactured to specification
Z-1679-2021 June 2, 2021 Mahwah, NJ
Nobel Biocare Procera LLC
Class II Terminated
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s...
Reason: Not manufactured to specification
Z-1677-2021 June 2, 2021 Mahwah, NJ
Nobel Biocare Procera LLC
Class II Terminated
NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s...
Reason: Not manufactured to specification
Z-1681-2021 June 2, 2021 Mahwah, NJ
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a pa...
Reason: The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Z-1650-2021 May 26, 2021 Mounds View, MN
Boston Scientific Corporation
Class I Ongoing
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Reason: The firm has received reports of stent migration after implantation
Z-1591-2021 May 26, 2021 Maple Grove, MN
Boston Scientific Corporation
Class I Ongoing
VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Reason: The firm has received reports of stent migration after implantation
Z-1592-2021 May 26, 2021 Maple Grove, MN
Bard Peripheral Vascular Inc
Class II Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for inf...
Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1552-2021 May 19, 2021 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for in...
Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1550-2021 May 19, 2021 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for in...
Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1551-2021 May 19, 2021 Tempe, AZ
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronizati...
Reason: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV...
Z-1526-2021 May 12, 2021 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of hea...
Reason: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV...
Z-1525-2021 May 12, 2021 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device tri...
Z-1522-2021 May 12, 2021 Mounds View, MN
Medtronic Neuromodulation
Class II Ongoing
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator ...
Reason: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Z-1535-2021 May 12, 2021 Minneapolis, MN