—#113483

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.

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K063341
Affected lot / code info: Model # INT510, Lot # 2011090751

Why it was recalled

Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-08-03
Posted by FDA: 2012-10-23
Terminated: 2012-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.