Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catal…
Labeling contains claims that are not consistently present.
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 105 recalls
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Labeling contains claims that are not consistently present.
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is appl…
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Polyaxial screws do not meet performance standards.
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
Potential for a weak seal in some units resulting in compromise in sterility.
Due to incomplete seals in the pouch which provide the sterile barrier.