Medical device recalls

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Impactor handle may be missing cross-pin

Impactor handle may be missing cross-pin

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

The device does not bear a unique device identifier.

Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.

It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

Behind-the-ear sound processer packaging label is different then included product.

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.