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
- Recall Number
- Z-0727-2018
- Event Number
- 79110
- Firm
- Keystone Dental Inc
- FEI Number
- 3005990499
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 25, 2017
- Terminated
- April 16, 2019
- Address
- 154 Middlesex Tpke, Burlington, MA, 01803-4403
Description
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.
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.
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
Nationally.
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