Legacy™ Healing Collar 8045-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307111337), received between Mar 9, 2018 and Dec 30, 2025 — classified as 3 injuries, 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K061319); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Positioning Failure; Insufficient Device Problem Information; Positioning Failure; Insufficient Device Problem Information

  PART NOT FUNCTIONAL.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928110 ↗
• InjuryMay 27, 2022Positioning Failure; Positioning Failure

  PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant

  MAUDE report 14521926 ↗
• InjuryDec 14, 2021Failure to Osseointegrate; Failure to Osseointegrate

  PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

  Patient problems: Failure of Implant

  MAUDE report 13006960 ↗
• MalfunctionMar 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PER (B)(4), (B)(4) DISTRIBUTOR REPORTED FINDING AN EXTRANEOUS BLACK PARTICLE ON THE HEALING COLLAR INSIDE A SEALED VIAL. THE PRODUCT WAS NOT DISTRIBUTED TO CUSTOMERS BUT THE ISSUE WAS NOTICED UPON RECEIPT INSPECTION AND RETURNED TO IMPLANT DIRECT FOR QA INSPECTION. QA PERFORMED A VISUAL INSPECTION SUBSTANTIATING THE CUSTOMERS CLAIM. THERE WAS A BLACK PARTICLE RESTING ON THE LARGEST DIAMETER OF THE HEALING COLLAR; HOWEVER, INVESTIGATION IS NOT YET COMPLETE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7329223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061319. One submission often covers many models, so check the product and lot details in each record.

• Z-0010-2020 · Aug 7, 2018 · Terminated
  ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousa
• Z-2376-2018 · May 18, 2018 · Terminated
  REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
• Z-2125-2017 · May 2, 2017 · Terminated
  Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
• Z-2320-2016 · Jul 5, 2016 · Terminated
  RePlant Angled Abutment Part Number 6050-52-60