Thursday, October 25, 2012

Dental Product Recalls Biomet 3i Dental Implant

Date Posted October 23, 2012
Recall Number Z-0119-2013
Product Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Code Information Model # INT510, Lot # 2011090751
Recalling Firm/
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mark Mashburn
Reason for
Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
Action Biomet 3 i sent an Urgent Medical Device Recall letter dated August 3, 2012, to all affected customers via e-mail, facsimile, telephone, or postal mail. Each customer was instructed to check their inventory for the affected product and provide feedback to Biomet 3i. Product is to be returned to: Biomet 3i P.M. Regulatory Compliance 4555 Riverside Drive Palm Beach Gardens, Florida 33410 For questions customers were instructed to call 1-800-342-5454. For questions regarding this recall call 561-776-6700.
Quantity in Commerce 227
Distribution Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.


dany chandra said...

Helpful blogs. It is the branded and professional Products For Dental services. Nice blog. I like it.

vito m said...

From time to time, you do get good posts here…

abp dental said...

this blog is totally based on dental and this blog is very useful to people a me to refer this blog to my friends and keep more posting through this blog thank you.
Dental products, gum disease