FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
- Recall number
- Z-0089-2019
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
- Status
- Terminated
- Initiated
- 2018-05-29
- Posted
- not on file
- Terminated
- 2020-07-29
- Reason
- Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
- Root cause
- Process control
- Action
- On May 29, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers via FedEx overnight mail. Customers were instruction to take the following actions: 1. Review your inventory for the affected product. 2. Complete and return the Acknowledgement Form within 48 hours for the product listed; Quarantine and return impacted product. 3. Authorized Implant Direct Sybron Manufacturing LLC distributors, should identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within48 hours of receipt of the notification. Customers with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.
- Quantity
- 217 units
- Distribution
- Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
- Lot, serial or model codes
- Part number 8735-05, Lot number 90212
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- 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