FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: Certain Preformance Post Dental implants
- Recall number
- Z-2492-2016
- Recalling firm
- Biomet 3i, LLC
- Product
- Certain Preformance Post Dental implants
- Status
- Terminated
- Initiated
- 2015-11-25
- Posted
- 2016-08-12
- Terminated
- 2019-07-26
- Reason
- Pouches may not have been sealed during packing.
- Root cause
- Packaging
- 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.
- Quantity
- 1,648,273 devices (all products subject to this recall)
- Distribution
- 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.
- Lot, serial or model codes
- Items: IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664 and IWPFP666.
- 510(k) numbers
- ["K053170","K072642"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28