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Implants & Prosthetics

ðŸĨ Medical Devices â€Ē 4,589 recalls

various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.

Zimmer Biomet

Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

Zimmer Biomet

Class I - Dangerous

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Feb 17, 2017 Implants & Prosthetics Nationwide View Details →

The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.

Medtronic Neurosurgery

Class I - Dangerous

Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.

Feb 22, 2017 Implants & Prosthetics View Details →
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