First, please allow me to clarify due to the fact you clowns cant read. The recall was due to a change in the IFU. That means "instruction for use" and is part of the 510K. The FDA has to be notified if anything is modified AFTER 510k approval. /QUOTE]
Zimmer rep - if you answer these questions, it would clarify issues:
What was the change in the IFU that was necessitated by the apical fracture?
Does your Screw-Vent have the same precautions during insertion or is it unique to TM?
Does your IFU for Screw-Vent require splinting of implants in the posters rather than being able to function freestanding?
Does the TM surface replacing half of the threaded surface of the Screw-Vent increase or decrease the chance for success with immediate loading?
Ok, here ya go:
1) The change required in the IFU for the 4.1 TM Implant discussed a "very dense bone" protocol. It said follow the regular outlined protocols but in very dense bone go 1 drill further in the Surgical Kit.
2) The Screw-Vent does not come in 4.1 diameters (3.7, 4.7 and 6.0). The Tapered Screw-Vent has the same protocol as the 4.1 TM with the exception of the additional drill recomendation in very dense bone. However, in very dense bone with the regular 4.1 TSV, the Bone Tap is the final "optional" recomendation in the protol.
3) The Screw-Vent or Tapered Screw-Vent are not required to be splinted in the posterior.
4) The TM Implant along with the TSV cary very clear FDA Indications in their IFU's for "Immediate Load". That means you can Immediate Load TM and TSV where determined appropriate by the Surgeon.
*Hope that helps.