Replace Select™ 29402 (UDI 07332747159653)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered TiU NP 3.5x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Replace Select implant is placed into bone, and its 501 reports, including 486 injuries, mostly describe the implant not bonding with the bone or losing its hold. Reports also list infection, pain, and numbness. There are no deaths reported, and 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
- 511
- Deaths reported
- 0
- Injuries reported
- 496
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 511 adverse event reports that list this exact device (DI 07332747159653), received between Oct 29, 2021 and Sep 17, 2026 — classified as 496 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (224 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 Osseointegration224
- Failure to Osseointegrate217
- Fracture34
- Osseointegration Problem22
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information3
- Material Deformation3
- Migration2
Patient problems
- Failure of Implant264
- No Clinical Signs, Symptoms or Conditions152
- Unspecified Infection68
- Pain29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
- Numbness12
- Implant Pain9
- Fistula6
Recent adverse event reports
The 25 most recent of 511 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811902 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811901 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811895 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811893 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811892 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811890 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796224 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796223 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796222 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796221 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382720 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228529 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228519 ↗InjuryAug 6, 2026Osseointegration Problem
Primary stability couldn¿t be achieve.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50167877 ↗InjuryAug 6, 2026Osseointegration Problem
Primary stability couldn¿t be achieved.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50167876 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092496 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092494 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030171 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030170 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863422 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25755265 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25755264 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754890 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754863 ↗InjuryJul 1, 2026Loss of Osseointegration
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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