Operativ can ship Ground or Express at the direction of the recipient. There is a $10 handling fee that is applied to your Invoice. If using your shipper account, Operativ will obtain the account number and use this number when creating the shipping label. If using our account, there is a minimum $25 charge or the actual amount of shipping cost, whichever is greater.
OPERATIV does not offer single sterile batteries. We currently offer one box which contains (10) individual sterile batteries.
Expired batteries should be disposed of according to your local regulations.
Sterile batteries are good for 2 years.
The voltage in a lithium battery should last about 2-3 years sitting on the shelf unused.
The battery should not be put in an autoclave due to the extremely high temperature having an adverse effect.
Each box contains one battery per sterile pack and 10 packs per box.
Lithium batteries can be disposed, with no fee, at a household hazardous waste facility where the materials in the batteries will be reclaimed and recycled. Drop off and mail back recycling options can be found online at Call2Recycle.org or by following the facilities protocols/procedures for disposal of lithium containing batteries.
The EtO (Ethylene-oxide) battery packaging and sterilization process is a very specific and lengthy process. The process involves exposing products to ethylene oxide gas under vacuum in a sealed chamber. Operativ’s packaging and sterilization validation is fully compliant with FDA requirements and are documented according to FDA standards.
All the Operativ pins are manufactured with 316L, F138 standard surgical implant grade stainless steel.
The Precision Pin is a giant step forward to improve accuracy in total knee arthroplasties, whether you are using Computer Navigation or traditional methods. The trocar tip design allows the Precision Pin to engage sclerotic or uneven bone without skiving. The thread count and pitch of the Precision Pin are designed specifically to allow smooth effortless insertion into the bone. The thread design of the Precision Pin does not require you to engage the second cortex, thus decreasing the risk of stress risers and fracture. The Precision Pin leaves a smaller hole than a similar sized traditional drill bit and compresses bone rather than evacuates bone to further reduce the risk of fracture. (Lindsay, et al., Sources of Error in Total Knee Replacement: The Use of Standard Fixation Pins vs Precision Pins for Placement of Cutting Blocks)
The pins are designed for single use only. It is very difficult to remove 100% of the bioburden within the threads or flutes of the pins. The straightness and integrity of the pin cannot be guaranteed beyond a single use.
Reprocessing and reusing single-use devices (SUDs) can save costs and reduce medical waste. Before medical devices can be reprocessed and reused, a third-party or hospital reprocessing department must comply with the same requirements that apply to original equipment manufacturers, including:
Submitting documents for premarket notification or approval.
Registering reprocessing firms and listing all products.
Submitting adverse event reports.
Tracking devices whose failure could have serious outcomes.
Correcting or removing from the market unsafe devices.
Meeting manufacturing and labeling requirements.