Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
FDA Recall Z-0564-2016 · Posted 2015-12-31
Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNDP
Date Initiated2015-11-16
Date Terminated2016-12-14
Product Quantity686
Reason for Recall
Images contained within radiographic transparency ART 1036 are undersized.
Firm Action
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 [email protected] 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.
Root Cause
Software design (manufacturing process)
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.