FDA Device

S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head

Hazard

Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

What You Should Do

Remedy

IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.

Products

S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
Brand
3m Imtec Corporation
UPC
Lot #035D10188

Units Affected

189 Implants