Z-0727-2018Class II

Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use...

Name: Z-0727-2018 Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use...
Creator: Keystone Dental Inc
Published: 2017-08-25
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2017-08-25 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of 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... on 2017-08-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0727-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-25
Posted: 2018-02-27
Terminated: 2019-04-16
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.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 20
Distribution: Nationally.
Product codes and lots: Catalog# S2400K, Lot 34276

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-27

Product code DZE

K072768Class IIRestore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc. / cleared 2007-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)