Prima Implant System 15628KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D76815628K0), received between Sep 28, 2021 and Sep 28, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K051614, K072768); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 12544666 ↗
• InjurySep 28, 2021Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Pain

  MAUDE report 12544652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051614, K072768. One submission often covers many models, so check the product and lot details in each record.

• Z-2162-2018 · May 1, 2018 · Terminated
  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
• Z-1179-2018 · Oct 16, 2017 · Terminated
  STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
• Z-0727-2018 · Aug 25, 2017 · Terminated
  Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support
• Z-0608-2018 · Jun 20, 2017 · Terminated
  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
• Z-1818-2017 · Mar 9, 2017 · Terminated
  Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
• Z-0299-2017 · Sep 15, 2016 · Terminated
  Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles a
• Z-0973-2013 · Mar 11, 2013 · Terminated
  PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.