Medical equipment, implants, and diagnostic devices
Galt Medical
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Implant Direct Sybron Manufacturing
The main vial label lists the incorrect part number, but the cap label is correct.
Products do not meet a tensile strength specification
The product label has missing information, such as the lot number and expiration date, as well as other information.
Products do not meet a tensile strength specification
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
Abbott Laboratories
Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
Siemens Medical Solutions USA
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Olympus Corporation of the Americas
Potential breakage of the endoscope s insertion tube bending section during surgical procedures
Olympus Corporation of the Americas
Breakage of the endoscope's insertion tube bending section during surgical procedures.
Life Technologies
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Life Technologies
It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.
Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
Products do not meet a tensile strength specification
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.