FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
- Recall number
- Z-2551-2018
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
- Status
- Terminated
- Initiated
- 2017-03-03
- Posted
- not on file
- Terminated
- 2018-08-06
- Reason
- The main vial label lists the incorrect part number, but the cap label is correct.
- Root cause
- Process control
- Action
- Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017.
- Quantity
- 124 units
- Distribution
- Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
- Lot, serial or model codes
- Lot #87837
- 510(k) numbers
- ["K130572"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3001617766
- Firm city
- Thousand Oaks
- Firm state
- CA
- 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