Food, drugs, devices › Keystone Dental Inc
Device recall: Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partia
FDA enforcement event 79040 is a device recall by Keystone Dental Inc of Burlington, MA, initiated 20 Jun 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 9 Apr 2018. Initiation: voluntary: firm initiated. Keystone Dental Inc has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Keystone Dental Inc, Burlington, MA.
Reason for recall
"Abutments are unable to accept the final abutment screw"
Distribution
"US Nationwide Distribution in the states of ND, NJ & MA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0608-2018 | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: 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… | 20 units | Class II | Terminated | 21 Feb 2018 |
Context
Other enforcement events for Keystone Dental Inc
All 12 events for Keystone Dental Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Abutments are unable to accept the final abutment screw"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of ND, NJ & MA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Apr 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.