NobelReplaceRecalls & reported problems across all models
Nobel Biocare AB · 120 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 138,221
- Deaths reported
- 0
- Injuries reported
- 137,097
- Recalls
- 15
We found 120 models of NobelReplace by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 138,221 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2017 and Sep 30, 2026 — classified as 137,097 injuries, 1,124 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (84,145 reports).
15 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NobelReplace recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 17, 2021Terminated
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Z-0658-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 20, 2020Terminated
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Z-2828-2020 · Root cause: Process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1315-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1314-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1313-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1312-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1311-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1310-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1309-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1308-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1307-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1306-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1304-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1303-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
- Mar 14, 2019Terminated
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Z-1302-2020 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported NobelReplace problems
Device problems
- Failure to Osseointegrate84,145
- Loss of Osseointegration43,286
- Osseointegration Problem5,337
- Adverse Event Without Identified Device or Use Problem1,665
- Fracture1,348
- Patient Device Interaction Problem695
- Migration489
- Insufficient Device Problem Information311
Patient problems
- Failure of Implant93,859
- No Clinical Signs, Symptoms or Conditions31,824
- Unspecified Infection15,541
- Pain12,297
- Numbness2,531
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1,655
- Inflammation1,416
- Abscess1,279
NobelReplace models
120 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NobelReplace® 36705IMPLANT, ENDOSSEOUS, ROOT-FORM11,654 reports
- NobelReplace® 37291IMPLANT, ENDOSSEOUS, ROOT-FORM8,582 reports
- NobelReplace® 36700IMPLANT, ENDOSSEOUS, ROOT-FORM7,955 reports
- NobelReplace® 36711IMPLANT, ENDOSSEOUS, ROOT-FORM5,742 reports
- NobelReplace® 37290IMPLANT, ENDOSSEOUS, ROOT-FORM5,696 reports
- NobelReplace® 36701IMPLANT, ENDOSSEOUS, ROOT-FORM5,618 reports
- NobelReplace® 36704IMPLANT, ENDOSSEOUS, ROOT-FORM4,975 reports
- NobelReplace® 37285IMPLANT, ENDOSSEOUS, ROOT-FORM4,728 reports
- NobelReplace® 32216IMPLANT, ENDOSSEOUS, ROOT-FORM4,411 reports
- NobelReplace® 37295IMPLANT, ENDOSSEOUS, ROOT-FORM4,368 reports
- NobelReplace® 36707IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall4,083 reports
- NobelReplace® 37296IMPLANT, ENDOSSEOUS, ROOT-FORM4,012 reports
- NobelReplace® 36710IMPLANT, ENDOSSEOUS, ROOT-FORM3,883 reports
- NobelReplace® 37287IMPLANT, ENDOSSEOUS, ROOT-FORM3,329 reports
- NobelReplace® 32217IMPLANT, ENDOSSEOUS, ROOT-FORM3,082 reports
- NobelReplace® 32220IMPLANT, ENDOSSEOUS, ROOT-FORM3,046 reports
- NobelReplace® 37292IMPLANT, ENDOSSEOUS, ROOT-FORM2,944 reports
- NobelReplace® 36708IMPLANT, ENDOSSEOUS, ROOT-FORM2,443 reports
- NobelReplace® 36702IMPLANT, ENDOSSEOUS, ROOT-FORM2,418 reports
- NobelReplace® 36705IMPLANT, ENDOSSEOUS, ROOT-FORM2,363 reports
- NobelReplace® 36699IMPLANT, ENDOSSEOUS, ROOT-FORM2,217 reports
- NobelReplace® 32212IMPLANT, ENDOSSEOUS, ROOT-FORM2,042 reports
- NobelReplace® 37284IMPLANT, ENDOSSEOUS, ROOT-FORM1,767 reports
- NobelReplace® 37288IMPLANT, ENDOSSEOUS, ROOT-FORM1,725 reports
- NobelReplace® 32215IMPLANT, ENDOSSEOUS, ROOT-FORM1,615 reports
- NobelReplace® 36707IMPLANT, ENDOSSEOUS, ROOT-FORM1,604 reports
- NobelReplace® 36700IMPLANT, ENDOSSEOUS, ROOT-FORM1,551 reports
- NobelReplace® 32213IMPLANT, ENDOSSEOUS, ROOT-FORM1,518 reports
- NobelReplace® 37293IMPLANT, ENDOSSEOUS, ROOT-FORM1,492 reports
- NobelReplace® 32219IMPLANT, ENDOSSEOUS, ROOT-FORM1,383 reports
- NobelReplace® 36701IMPLANT, ENDOSSEOUS, ROOT-FORM1,339 reports
- NobelReplace® 36711IMPLANT, ENDOSSEOUS, ROOT-FORM1,338 reports
- NobelReplace® 36712IMPLANT, ENDOSSEOUS, ROOT-FORM1,303 reports
- NobelReplace® 36704IMPLANT, ENDOSSEOUS, ROOT-FORM1,243 reports
- NobelReplace® 36101IMPLANT, ENDOSSEOUS, ROOT-FORM1,159 reports
- NobelReplace® 32221IMPLANT, ENDOSSEOUS, ROOT-FORM1,048 reports
- NobelReplace® 36708IMPLANT, ENDOSSEOUS, ROOT-FORM1,027 reports
- NobelReplace® 36702IMPLANT, ENDOSSEOUS, ROOT-FORM957 reports
- NobelReplace® 36699IMPLANT, ENDOSSEOUS, ROOT-FORM873 reports
- NobelReplace® 32211IMPLANT, ENDOSSEOUS, ROOT-FORM868 reports
- NobelReplace® 36710IMPLANT, ENDOSSEOUS, ROOT-FORM821 reports
- NobelReplace® 37297IMPLANT, ENDOSSEOUS, ROOT-FORM772 reports
- NobelReplace® 37291IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall715 reports
- NobelReplace® 36712IMPLANT, ENDOSSEOUS, ROOT-FORM658 reports
- NobelReplace® 36100IMPLANT, ENDOSSEOUS, ROOT-FORM562 reports
- NobelReplace® 37285IMPLANT, ENDOSSEOUS, ROOT-FORM517 reports
- NobelReplace® 36102IMPLANT, ENDOSSEOUS, ROOT-FORM499 reports
- NobelReplace® 36713IMPLANT, ENDOSSEOUS, ROOT-FORM495 reports
- NobelReplace® 37290IMPLANT, ENDOSSEOUS, ROOT-FORM467 reports
- NobelReplace® 32218IMPLANT, ENDOSSEOUS, ROOT-FORM426 reports
- NobelReplace® 36713IMPLANT, ENDOSSEOUS, ROOT-FORM423 reports
- NobelReplace® 37292IMPLANT, ENDOSSEOUS, ROOT-FORM417 reports
- NobelReplace® 32224IMPLANT, ENDOSSEOUS, ROOT-FORM363 reports
- NobelReplace® 37293IMPLANT, ENDOSSEOUS, ROOT-FORM355 reports
- NobelReplace® 36703IMPLANT, ENDOSSEOUS, ROOT-FORM339 reports
- NobelReplace® 37284IMPLANT, ENDOSSEOUS, ROOT-FORM312 reports
- NobelReplace® 36709IMPLANT, ENDOSSEOUS, ROOT-FORM312 reports
- NobelReplace® 37287IMPLANT, ENDOSSEOUS, ROOT-FORM311 reports
- NobelReplace® 37296IMPLANT, ENDOSSEOUS, ROOT-FORM305 reports
- NobelReplace® 37298IMPLANT, ENDOSSEOUS, ROOT-FORM302 reports
- NobelReplace® 32182IMPLANT, ENDOSSEOUS, ROOT-FORM282 reports
- NobelReplace® 37288IMPLANT, ENDOSSEOUS, ROOT-FORM271 reports
- NobelReplace® 37295IMPLANT, ENDOSSEOUS, ROOT-FORM265 reports
- NobelReplace® 37294IMPLANT, ENDOSSEOUS, ROOT-FORM237 reports
- NobelReplace® 32183IMPLANT, ENDOSSEOUS, ROOT-FORM236 reports
- NobelReplace® 37298IMPLANT, ENDOSSEOUS, ROOT-FORM235 reports
- NobelReplace® 37289IMPLANT, ENDOSSEOUS, ROOT-FORM233 reports
- NobelReplace® 32181IMPLANT, ENDOSSEOUS, ROOT-FORM232 reports
- NobelReplace® 36709IMPLANT, ENDOSSEOUS, ROOT-FORM227 reports
- NobelReplace® 32214IMPLANT, ENDOSSEOUS, ROOT-FORM212 reports
- NobelReplace® 36703IMPLANT, ENDOSSEOUS, ROOT-FORM212 reports
- NobelReplace® 32187IMPLANT, ENDOSSEOUS, ROOT-FORM202 reports
- NobelReplace® 32186IMPLANT, ENDOSSEOUS, ROOT-FORM188 reports
- NobelReplace® 32223IMPLANT, ENDOSSEOUS, ROOT-FORM167 reports
- NobelReplace® 36897IMPLANT, ENDOSSEOUS, ROOT-FORM167 reports
- NobelReplace® 37297IMPLANT, ENDOSSEOUS, ROOT-FORM128 reports
- NobelReplace® 36714IMPLANT, ENDOSSEOUS, ROOT-FORM125 reports
- NobelReplace® 36842IMPLANT, ENDOSSEOUS, ROOT-FORM124 reports
- NobelReplace® 32225IMPLANT, ENDOSSEOUS, ROOT-FORM113 reports
- NobelReplace® 32184IMPLANT, ENDOSSEOUS, ROOT-FORM108 reports
- NobelReplace® 32188IMPLANT, ENDOSSEOUS, ROOT-FORM106 reports
- NobelReplace® 32222IMPLANT, ENDOSSEOUS, ROOT-FORM102 reports
- NobelReplace® 37045Accessories, implant, dental, endosseous2 recalls0 reports
- NobelReplace® 36898IMPLANT, ENDOSSEOUS, ROOT-FORM94 reports
- NobelReplace® 36714IMPLANT, ENDOSSEOUS, ROOT-FORM92 reports
- NobelReplace® 37294IMPLANT, ENDOSSEOUS, ROOT-FORM89 reports
- NobelReplace® 36103IMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- NobelReplace® 32162IMPLANT, ENDOSSEOUS, ROOT-FORM82 reports
- NobelReplace® 36844IMPLANT, ENDOSSEOUS, ROOT-FORM77 reports
- NobelReplace® 36896IMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- NobelReplace® 36899IMPLANT, ENDOSSEOUS, ROOT-FORM71 reports
- NobelReplace® 37289IMPLANT, ENDOSSEOUS, ROOT-FORM71 reports
- NobelReplace® 32161IMPLANT, ENDOSSEOUS, ROOT-FORM68 reports
- NobelReplace® 36841IMPLANT, ENDOSSEOUS, ROOT-FORM66 reports
- NobelReplace® 37299IMPLANT, ENDOSSEOUS, ROOT-FORM62 reports
- NobelReplace® 37299IMPLANT, ENDOSSEOUS, ROOT-FORM60 reports
- NobelReplace® 36843IMPLANT, ENDOSSEOUS, ROOT-FORM58 reports
- NobelReplace® 32737Accessories, implant, dental, endosseous1 recall0 reports
- NobelReplace® 37098Accessories, implant, dental, endosseous1 recall0 reports
- NobelReplace® 37095Accessories, implant, dental, endosseous1 recall0 reports
Recent NobelReplace adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50954502 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50954500 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50954499 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50954496 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954487 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954485 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954484 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954478 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: Sinus Perforation
MAUDE report 50954471 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: Sinus Perforation
MAUDE report 50954470 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50954440 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50954439 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954287 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954286 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50954281 ↗
Other Nobel Biocare AB products
- NobelActive56 models · 152,066 reports
- NobelParallel54 models · 132,525 reports
- NobelActive TiUltra28 models · 82,969 reports
- NobelParallel Conical Connection TiUltra27 models · 68,868 reports
- Replace Select107 models · 33,616 reports
- NobelReplace Conical Connection TiUltra15 models · 31,165 reports
- NobelSpeedy88 models · 24,246 reports
- Brånemark System141 models · 19,899 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page