RegWardenFDA facility compliance records
Recall

Class II — Keystone Dental Inc

Recalling firmKeystone Dental Inc.
Registered facilityKeystone Dental Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe 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.
ProductStage-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.
Quantity20
DistributionNationally.
Initiated2017-08-25
Classified2018-02-27
Terminated2019-04-16
Recall numberZ-0727-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Keystone Dental Inc (Z-0727-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79110/

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