Z-0973-2013Class II

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support...

Name: Z-0973-2013 PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support...
Creator: Keystone Dental Inc
Published: 2013-03-11
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2013-03-11 / Terminated / root cause: packaging

FDA source

Keystone Dental Inc began a recall of PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework on 2013-03-11. FDA classified it as Class II and gives the reason as "Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0973-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Posted: 2013-03-20
Terminated: 2013-09-26
Recalling firm: Keystone Dental Inc.
Product: PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
Quantity in commerce: 120 units
Distribution: Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Product codes and lots: Lot Number: 12857

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0973-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0973-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-20

Product code NDP

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)