Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Class I - Dangerous
Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
Class I - Dangerous
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
Osteogenics Biomedical
Class I - Dangerous
The device has the potential to be packaged in the wrong product box.
Class I - Dangerous
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging
Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Class I - Dangerous
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.
Class I - Dangerous
Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.