Recalls / —
—#146800
Product
Standard Abutment Dental implants
- FDA product code
- NHA — Abutment, Implant, Dental, Endosseous
- Device class
- Class 2
- Medical specialty
- Dental
- 510(k) numbers
- K072642
- Affected lot / code info
- Item: AB200, AB300, AB400, AB500 and AB700.
Why it was recalled
Pouches may not have been sealed during packing.
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Biomet 3i, LLC
- Address
- 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200
Distribution
- 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.
Timeline
- Recall initiated
- 2015-11-25
- Posted by FDA
- 2016-08-12
- Terminated
- 2019-07-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146800. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.