Medical Devices Recalls

STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.

Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.

Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect.

Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.

Screw inserters may not mate properly with hex interface of the screws.

An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

Mismarked and unmarked screws

Mismarked and unmarked screws

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

Screw inserters may not mate properly with hex interface of the screws.

Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.

Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.