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.
FDA Recall Z-0727-2018 · Posted None
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Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-08-25
Date Terminated2019-04-16
Product Quantity20
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.
Firm 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
Root Cause
Error in labeling
Distribution Pattern
Nationally.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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