Terminated

Standard Abutment Dental implants

FDA Recall Z-2443-2016 · Posted 2016-08-12

Recalling FirmBiomet 3i, LLC

Recall StatusTerminated

Product CodeNHA

Date Initiated2015-11-25

Date Terminated2019-07-26

Product Quantity1,648,273 devices (all products subject to this recall)

Reason for Recall

Pouches may not have been sealed during packing.

Firm Action

Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316. For questions regarding this recall call 561-776-6700.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072642BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTSBiomet 3i, Inc. · 2007-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.