Integra LifeSciences Recalls

Hazard: Incorrect gel part number listed in a master manufacturing record

Hazard: A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.

Hazard: Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.

Hazard: A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two scenarios when the failure mode may occur: 1) Ultrasonic fragmentation may be inadvertently activated at start-up or at the initial use once the footswitch is connected to the console and after the user primes the system, performs a handpiece test, and enters the Main Screen. 2) Ultrasonic fragmentation may remain activated during surgical use once the foot pedal is disengaged slowly.

Hazard: Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

Hazard: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

Hazard: Posterior tibial fractures have been reported.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Hazard: Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750).

Hazard: Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.

Hazard: Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".

Hazard: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

Hazard: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

Hazard: The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Hazard: As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.

Hazard: The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.

Hazard: As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4, it is 6. 3) The space / holder

Hazard: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Hazard: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Hazard: Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.

Hazard: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.

Hazard: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Hazard: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Hazard: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Hazard: A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).