Medical Devices Recalls

GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.

Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

The products may have been stored at temperatures outside their required storage conditions.

Product not cleared for sale/use in the United States.

Product not cleared for sale/use in the United States.

A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run

The products may have been stored at temperatures outside their required storage conditions.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.