—#121745

Product

Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: 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.

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K100724
Affected lot / code info: XIIOS5411

Why it was recalled

One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.

Root cause (FDA determination)

Device Design

Action the firm took

Biomet 3i sent an Urgent: Medical Device Recall letter dated June 10, 2013 to affected customer via email, facsimile, or postal mail. The letter identified the affected product, problem, and actions to be taking. Customer were instructed to check their respective inventory for the affected product and return to Biomet 3i. Biomet 3i will issue replacement product. For questions or concerns call 1-800-342-5454.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, France, Switzerland, Apain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.

Timeline

Recall initiated: 2013-06-10
Posted by FDA: 2013-09-16
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.