CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Stage-1¿ RDS Indexed Abutment recalled by Keystone Dental
Keystone Dental is recalling Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s, distributed nationwide in the US. The recall was initiated on 25 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0727-2018
- FDA event ID
- 79110
- Recalling firm
- Keystone Dental, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2017
- FDA classified
- 27 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Dental Devices
Timeline
| 25 Aug 2017 | Recall initiated by company | |
| 27 Feb 2018 | Classified by FDA | +186 days |
| 7 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationally.
Questions about this recall
Is Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s recalled?
Yes. Keystone Dental recalled Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s on 25 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0727-2018.
Why was it recalled?
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.
Which lots are affected?
Catalog# S2400K, Lot 34276
Where was it sold?
Nationally.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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