—#141861

Product

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.

Why it was recalled

Images contained within radiographic transparency ART 1036 are undersized.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

BIOMET3i sent an" Urgent Medical Device Recall letter " dated November, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Responsibilities: 1. Please review this notice and check your inventory for the affected item by comparing any on-hand ART 1036 Transparencies to a standard 8.5" x 11" sheet of paper. The non-conforming ART 1036 is approximately 7.8" x 10.2". 2. Immediately quarantine and remove all affected items from service. 3. Complete the attached Business Reply Form and either: a. fax it to 561-514-6316 or b. email it to postmarket@biomet.com or c. return it along with the affected product using the included shipping label 4. Return affected product to BIOMET 3i. For assistance or other questions that you may have relative to this notice, please contact BIOMET 3i at 1- 800-342-5454 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.

Timeline

Recall initiated: 2015-11-16
Posted by FDA: 2015-12-31
Terminated: 2016-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141861. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.