NobelZygomaRecalls & reported problems across all models
Nobel Biocare AB · 36 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,167
- Deaths reported
- 0
- Injuries reported
- 2,106
- Recalls
- 0
We found 36 models of NobelZygoma by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 2,167 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2019 and Sep 19, 2026 — classified as 2,106 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,269 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. 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
Most reported NobelZygoma problems
Device problems
- Failure to Osseointegrate1,269
- Loss of Osseointegration443
- Osseointegration Problem158
- Fracture88
- Patient Device Interaction Problem58
- Adverse Event Without Identified Device or Use Problem54
- Migration26
- Activation, Positioning or Separation Problem18
Patient problems
- Failure of Implant1,580
- No Clinical Signs, Symptoms or Conditions420
- Pain218
- Unspecified Infection170
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available65
- Numbness47
- Abscess20
- Sinus Perforation13
NobelZygoma models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NobelZygoma™ 38289IMPLANT, ENDOSSEOUS, ROOT-FORM230 reports
- NobelZygoma™ 38287IMPLANT, ENDOSSEOUS, ROOT-FORM229 reports
- NobelZygoma™ 38288IMPLANT, ENDOSSEOUS, ROOT-FORM217 reports
- NobelZygoma™ 38285IMPLANT, ENDOSSEOUS, ROOT-FORM170 reports
- NobelZygoma™ 38291IMPLANT, ENDOSSEOUS, ROOT-FORM147 reports
- NobelZygoma™ 38290IMPLANT, ENDOSSEOUS, ROOT-FORM140 reports
- NobelZygoma™ 38286IMPLANT, ENDOSSEOUS, ROOT-FORM139 reports
- NobelZygoma™ 38284IMPLANT, ENDOSSEOUS, ROOT-FORM100 reports
- NobelZygoma™ 38292IMPLANT, ENDOSSEOUS, ROOT-FORM82 reports
- NobelZygoma™ 38283IMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- NobelZygoma™ 38285IMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- NobelZygoma™ 38291IMPLANT, ENDOSSEOUS, ROOT-FORM51 reports
- NobelZygoma™ 38289IMPLANT, ENDOSSEOUS, ROOT-FORM45 reports
- NobelZygoma™ 38290IMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- NobelZygoma™ 38288IMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- NobelZygoma™ 38283IMPLANT, ENDOSSEOUS, ROOT-FORM39 reports
- NobelZygoma™ 38276IMPLANT, ENDOSSEOUS, ROOT-FORM38 reports
- NobelZygoma™ 38284IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- NobelZygoma™ 38286IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- NobelZygoma™ 38278IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- NobelZygoma™ 38287IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- NobelZygoma™ 38279IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- NobelZygoma™ 38280IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- NobelZygoma™ 38275IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- NobelZygoma™ 38292IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- NobelZygoma™ 38277IMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- NobelZygoma™ 38276IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- NobelZygoma™ 38282IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- NobelZygoma™ 38280IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- NobelZygoma™ 38277IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- NobelZygoma™ 38278IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- NobelZygoma™ 38281IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- NobelZygoma™ 38281IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- NobelZygoma™ 38282IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- NobelZygoma™ 38279IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- NobelZygoma™ 38275IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent NobelZygoma adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833531 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833530 ↗InjurySep 14, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749139 ↗InjurySep 14, 2026Osseointegration Problem
Lack of stability during placement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749138 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743901 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50743899 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50724415 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50724413 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724402 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724400 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724399 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724398 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724396 ↗
Other Nobel Biocare AB products
- NobelActive56 models · 152,066 reports
- NobelReplace120 models · 138,221 reports · 15 recalls
- 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
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.
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