FDA Medical Device Recalls (openFDA)
Biomet 3i: Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
- Recall number
- Z-0128-2008
- Recalling firm
- Biomet 3i
- Product
- Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
- Status
- Terminated
- Initiated
- 2007-10-08
- Posted
- 2008-01-17
- Terminated
- 2008-07-10
- Reason
- Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.
- Root cause
- Process control
- Action
- Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.
- Quantity
- 114
- Distribution
- Worldwide Distribution - USA, Italy, France, Spain and UK.
- Lot, serial or model codes
- Lot Number: 707303, Expiration Date: 08/31/2012
- 510(k) numbers
- ["K060291"]
- 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