Implant

STERILITY OF TMJ IMPLANT COMPONENTS

The TMJ mandibular and glenoid fossa components are packaged in double Tyvek/film pouches and have been sterilized using an ethylene oxide gas cycle that has been shown to produce terminally sterile product with a sterility assurance level of 10-6 and residual levels below ANSI/AIMI/ISO 10993-7 limits and FDA proposed limits.

DO NOT USE COMPONENTS IN OPEN OR DAMAGED PACKAGING.

RESTERILIZATION INSTRUCTIONS FOR TMJ IMPLANT COMPONENTS

In the event that a TMJ implant component needs to be resterilized, it may be returned to TMJ Concepts for repackaging and resterilization.

Alternatively, clean TMJ implant components may be repackaged into double Tyvek/film or paper/film peel pouches per standard hospital practice and resterilized using one of the ethylene oxide (EO) gas cycles listed below. It is recommended that the components be processed by themselves with no other products in the sterilization chamber. It is the responsibility of the customer to demonstrate the appropriateness of the sterilization cycle used should it vary from those listed.

 
These cycles have been shown to produce terminally sterile product with a sterility assurance level of 10 6 and residual levels below ANSI/AIMI/ISO 10993-7 limits and FDA proposed limits when used on clean TMJ implant components.

DO NOT RESTERILIZE COMPONENTS THAT HAVE BEEN IMPLANTED OR HAVE BECOME CONTAMINATED WITH DEBRIS, RESIDUE, OR BODY FLUIDS. IN THESE INSTANCES, THE COMPONENTS SHOULD BE RETURNED TO TMJ CONCEPTS.

DO NOT STEAM STERILIZE THE GLENOID FOSSA COMPONENT AS DAMAGE TO THE PLASTIC PORTION MAY OCCUR.

STERILIZATION INSTRUCTIONS FOR SCREWS

The screws are intended for steam sterilization in the TMJ Fixation Hardware Sterilization Case provided by TMJ Concepts. The following sterilization cycle has been shown to produce terminally sterile product with a sterility assurance level of 10-6. Other similar steam cycles may be used but have not been evaluated.

Wrapped or Unwrapped Prevacuum Steam Sterilization,
15 minutes at 270-275°F (133-135°C)