Replace Select™ 36109 (UDI 07332747022698)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU WP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select tapered implant has 193 reports, 192 injuries and no deaths. Almost all describe the implant not bonding with the bone or losing its bond, and a fair number mention pain or infection. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 194
- Deaths reported
- 0
- Injuries reported
- 193
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 07332747022698), received between Sep 11, 2019 and Aug 21, 2026 — classified as 193 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (110 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration110
- Failure to Osseointegrate74
- Osseointegration Problem3
- Fracture2
- Insufficient Device Problem Information2
- Material Deformation2
- Malposition of Device1
Patient problems
- Failure of Implant175
- Pain28
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions10
- Numbness7
- Insufficient Information2
- Abscess1
Recent adverse event reports
The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806630 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806626 ↗InjuryJun 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586842 ↗InjuryJun 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586840 ↗InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453709 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453632 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453297 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22453295 ↗InjuryJul 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22400049 ↗InjuryJul 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22400044 ↗InjuryMar 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19734427 ↗InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19734347 ↗InjuryJun 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19590185 ↗InjuryJun 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19589250 ↗InjuryJun 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19524182 ↗InjuryJun 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19523708 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.