Z-0608-2018Class II

Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K

Name: Z-0608-2018 Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K
Creator: Keystone Dental Inc
Published: 2017-06-20
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2017-06-20 / Terminated

FDA source

Keystone Dental Inc began a recall of 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... on 2017-06-20. FDA classified it as Class II and gives the reason as "Abutments are unable to accept the final abutment screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0608-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-20
Posted: 2018-02-14
Terminated: 2018-04-09
Recalling firm: Keystone Dental Inc.
Product: 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 intermediate abutment support for fixed bridgework.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Abutments are unable to accept the final abutment screw
FDA root cause: Other
Action: On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272.
Quantity in commerce: 20 units
Distribution: US Nationwide Distribution in the states of ND, NJ & MA
Product codes and lots: REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0608-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0608-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code NHA

K051614Class IIPrimaconnex Internal Connection Implant System, Primaconnex Internal Connection ProstheticsLifecore Biomedical, Inc. / cleared 2005-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)