Recalls / —

—#134181

Product

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

FDA product code

DZE — Implant, Endosseous, Root-Form

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K130949

Affected lot / code info

Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018

Why it was recalled

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Root cause (FDA determination)

Manufacturing material removal

Action the firm took

Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Recalling firm

Firm

Biomet 3i, LLC

Address

4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

Timeline

Recall initiated

2014-11-07

Posted by FDA

2015-04-10

Terminated

2015-05-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #134181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.