FDA Medical Device Recalls (openFDA)
Keystone Dental Inc: Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
- Recall number
- Z-0727-2018
- Recalling firm
- Keystone Dental Inc
- Product
- Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
- Status
- Terminated
- Initiated
- 2017-08-25
- Posted
- not on file
- Terminated
- 2019-04-16
- Reason
- The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
- Root cause
- Error in labeling
- Action
- On August 18, 2017 a letter titled "Product Action S2400K, Stage-1 RDS Indexed Abutment, Lot 34276" was issued to customers requesting persons to review their inventory and respond if product has been used or not. A response form is requested from these customers with instruction to return any unused product. Questions or concerns can be directed to: Customer Relations: Toll Free 866-902-9272
- Quantity
- 20
- Distribution
- Nationally.
- Lot, serial or model codes
- Catalog# S2400K, Lot 34276
- 510(k) numbers
- K072768
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3005990499
- Firm city
- Burlington
- Firm state
- MA
- 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