FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Recall number
- Z-0007-2018
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Status
- Terminated
- Initiated
- 2017-07-21
- Posted
- not on file
- Terminated
- 2021-04-01
- Reason
- The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
- Root cause
- Employee error
- Action
- Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.
- Quantity
- 50 units
- Distribution
- Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
- Lot, serial or model codes
- Product Code 9048-13H, Lot No. 81080
- 510(k) numbers
- ["K090234"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 3001617766
- Firm city
- Westlake Village
- 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