Replace® Select 28953Recalls & reported problems
Nobel Biocare AB · Replace Select Straight TiU RP 4.3x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 145 FDA adverse event reports, with no deaths and 145 injuries. Most describe the implant losing its bond with the jawbone, and patients were most often reported with implant failure. Some 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
- 145
- Deaths reported
- 0
- Injuries reported
- 145
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 07332747022551), received between Sep 15, 2019 and Jul 27, 2026 — classified as 145 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (120 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 Osseointegration120
- Failure to Osseointegrate17
- Fracture4
- Osseointegration Problem4
Patient problems
- Failure of Implant113
- Pain30
- Unspecified Infection22
- No Clinical Signs, Symptoms or Conditions16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Abscess2
- Implant Pain2
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026686 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026684 ↗InjuryJun 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571123 ↗InjuryJun 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571120 ↗InjuryJun 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571100 ↗InjuryJun 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571097 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25249435 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25249433 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25249431 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25249430 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24837453 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24837451 ↗InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24514543 ↗InjuryMar 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24509133 ↗InjuryMar 2, 2026Loss of Osseointegration
InjuryMar 2, 2026Loss of Osseointegration
InjuryMar 2, 2026Failure to Osseointegrate
InjuryMar 2, 2026Failure to Osseointegrate
InjuryFeb 27, 2026Loss of Osseointegration
InjuryFeb 27, 2026Loss of Osseointegration
InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784484 ↗InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784482 ↗InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23079481 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.