Medical Devices Recalls

The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, taps, screwdriver blades, and a screw holding sleeve. However, the device is not intended to be used in conjunction with a tap for tapping holes in a patient's skull, upper and/or lower jaw. Therefore some outlines in the graphic case suggest a potential use of this device that is considered off-label.

A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.

Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.

The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.

There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.

Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.

Potential for separation of dilator tips.

The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated

Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.

Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.

The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.

Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.