FDA Medical Device Recalls (openFDA)
Implant Direct Sybron Manufacturing, LLC: GoDirect Screw-Retaining Top Part Numbers: 4500-61
- Recall number
- Z-0961-2017
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Product
- GoDirect Screw-Retaining Top Part Numbers: 4500-61
- Status
- Terminated
- Initiated
- 2016-11-28
- Posted
- 2017-01-09
- Terminated
- 2017-02-16
- Reason
- Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
- Root cause
- Labeling mix-ups
- Action
- On 11/28/16 customers were called and instructed to return the product.
- Quantity
- 14
- Distribution
- U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.
- Lot, serial or model codes
- Lot #75808
- 510(k) numbers
- ["K090234"]
- PMA numbers
- not on file
- Product code
- DZE
- 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