Legacy™3 Implant 857013Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10841307102373), received between Jun 16, 2018 and Nov 24, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K192221); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

  FAILURE TO OSSEOINTEGRATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23639079 ↗
• InjurySep 27, 2024Loss of Osseointegration; Loss of Osseointegration

  PRODUCT COMPLETE: LOSS OF OSSEOINTEGRATION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 20317182 ↗
• InjurySep 10, 2024Positioning Failure; Positioning Failure

  LACK OF STABILITY DURING PLACEMENT.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 20183911 ↗
• InjuryJan 29, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 13389828 ↗
• InjuryFeb 16, 2021Osseointegration Problem; Osseointegration Problem

  PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

  Patient problems: Failure of Implant; Sinus Perforation; Unspecified Infection

  MAUDE report 11332139 ↗
• InjuryDec 9, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Failure of Implant; Tissue Breakdown

  MAUDE report 10973666 ↗
• InjuryMar 27, 2020Failure to Osseointegrate; Failure to Osseointegrate

  PER (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9887508 ↗
• InjuryMar 19, 2020Positioning Problem; Positioning Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, THERE WAS ERROR IN SURGICAL PROTOCOL.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 9852683 ↗
• InjurySep 9, 2019Loss of Osseointegration; Loss of Osseointegration

  PER COMPLAINT (B)(4), IMPLANT LOSS INTEGRATION. PATIENT EXPERIENCED PAIN AND INFLAMMATION.

  Patient problems: Failure of Implant; Inflammation; Pain

  MAUDE report 8977197 ↗
• InjurySep 6, 2019Positioning Problem; Positioning Problem

  AS PER COMPLAINT (B)(4), A DENTAL IMPLANT HAD A FAILURE TO INTEGRATE DURING A CLINICAL PROCEDURE AND THE IMPLANT WAS EXPLANTED. NO PATIENT EFFECT WAS RECORDED.

  Patient problems: Failure of Implant; Inflammation; No Information

  MAUDE report 8970537 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT (B)(4), A PATIENT PRESENTED ONE WEEK AFTER INITIAL PLACEMENT OF THEIR DENTAL IMPLANT FOR A CHECKUP WITH MILD DEHISCENCE ON THE BUCCAL BONE. THREE WEEKS AFTER PLACEMENT, THE PATIENT PRESENTED WITH VISIBLE MICRO-THREADS AT THE OCCLUSAL PORTION OF THE IMPLANT. A THROBBING SENSATION AND PAIN WERE ALSO REPORTED. THE DENTAL IMPLANT WAS REMOVED.

  Patient problems: Failure of Implant; Pain; Wound Dehiscence

  MAUDE report 8596401 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT (B)(4), A PATIENT EXPERIENCED PARESTHESIA OF THE LOWER LEFT LIP AND CHIN 14 DAYS AFTER INITIAL PLACEMENT OF THEIR DENTAL IMPLANT. THE IMPLANT WAS POSITIONED SUPERIOR TO THE INFERIOR ALVEOLAR NERVE CANAL. THE IMPLANT WAS REMOVED AND THE PATIENT IS TO BE OBSERVED FOR RECOVERY. REPLACEMENT IS PLANNED TO TAKE PLACE IN 3 MONTHS.

  Patient problems: Failure of Implant; Nerve Damage

  MAUDE report 8571537 ↗
• InjuryJun 16, 2018Failure to Osseointegrate; Failure to Osseointegrate

  PER THE COMPLAINT, DURING POST OPERATIVE APPOINTMENT, PATIENT PRESENT WITH PARASTHESIA OF LOWER LEFT LIP AND CHIN 14 DAYS AFTER PLACEMENT. THE IMPLANT WAS REMOVED. THE DOCTOR PLANS TO OBSERVE FOR RECOVERY AND TO REPLACE IN 3 MONTHS. IMPLANT #19 IN POSITION INTIMATE WITH SUPERIOR OF IAN CANAL. PATIENT SUFFERED NERVE DAMAGE.

  Patient problems: Failure of Implant; High Blood Pressure/ Hypertension; Nerve Damage; No Code Available

  MAUDE report 7608150 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192221. One submission often covers many models, so check the product and lot details in each record.

• Z-0197-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
• Z-0198-2022 · Sep 23, 2021 · Open, Classified
  ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,