Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Medtronic
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Medtronic
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Medtronic
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Medtronic
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Inspire Model 3028, IV Implantable Pulse Generator
Inspire Medical Systems
Class I - Dangerous
There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Medtronic
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class I - Dangerous
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class I - Dangerous
Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment