Z-1818-2017Class II

Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s)...

Name: Z-1818-2017 Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s)...
Creator: Keystone Dental Inc
Published: 2017-03-09
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2017-03-09 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K on 2017-03-09. FDA classified it as Class II and gives the reason as "Straight PrimaConnex Implants contained Tapered PrimaConnex Implants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1818-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Posted: 2017-04-13
Terminated: 2017-07-05
Recalling firm: Keystone Dental Inc.
Product: Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272
Quantity in commerce: 59 units
Distribution: CA, IL, IN, FL, MA, MN, NJ, NV, PA,
Product codes and lots: Lot Number: 30214

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1818-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1818-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-13

Product code DZE

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)