Z-2162-2018Class II

Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in...

Name: Z-2162-2018 Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in...
Creator: Keystone Dental Inc
Published: 2018-05-01
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2018-05-01 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae... on 2018-05-01. FDA classified it as Class II and gives the reason as "The implants are mislabeled". 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-2162-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Posted: 2018-06-11
Terminated: 2018-09-14
Recalling firm: Keystone Dental Inc.
Product: Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The implants are mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The Firm sent an Urgent Medical Device Correction letter dated April 30, 2018. In this discrepancy, the 5 is missing from the implant length description. Please note this discrepancy is limited to the implant package label only. The patient chart labels are all correct. Keystone Dental has performed a thorough review and determined there are no health hazards associated with this issue. There is no issue with the product within the package and the product can be safely used without issue in accordance with the defined surgical protocols. There is no risk of confusion of product size. The diameter is correct. Prima Plus implants are only available in 11.5mm lengths. The catalogs, surgical protocols and manuals only define procedures and provide instrumentation for placing 11.5mm length implants. Additionally, the patient chart labels contained within the implant package are correct so that patient procedure history will be properly maintained. The issue is limited to the label on the outside of the product package only. The lot identified above is the only affected lot. No other lots are affected with this issue. The product referenced above can be used safely without issue and no further action is required. For further questions, please call (866) 902-9272.
Quantity in commerce: 72
Distribution: US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
Product codes and lots: UDI: D76815737K0, Lot 37038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2162-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2162-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11

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)