Legacy2 ImplantRecalls & reported problems across all models
Implant Direct Sybron Manufacturing LLC · 78 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Legacy2 Implant model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8,257
- Deaths reported
- 1
- Injuries reported
- 8,127
- Recalls
- 2
We found 78 models of Legacy2 Implant by Implant Direct Sybron Manufacturing LLC in the FDA's device registry (GUDID). Together they are named in 8,257 adverse event reports in the FDA's MAUDE database, received between Feb 19, 2018 and Sep 30, 2026 — classified as 1 death, 8,127 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,680 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Legacy2 Implant 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.
- Sep 23, 2021Open, Classified
Packaged dental implant contains a different size then the size declared on the labeling.
Z-0198-2022 · Root cause: Packaging change control · Recall details · FDA record ↗
- Sep 23, 2021Open, Classified
Packaged dental implant contains a different size then the size declared on the labeling.
Z-0197-2022 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported Legacy2 Implant problems
Device problems
- Failure to Osseointegrate4,680
- Loss of Osseointegration1,233
- Positioning Failure806
- Osseointegration Problem655
- Positioning Problem427
- Fracture110
- Separation Failure90
- Malposition of Device67
Patient problems
- Failure of Implant6,850
- Osteopenia/ Osteoporosis1,470
- Inflammation1,179
- Inadequate Osseointegration1,126
- Unspecified Infection1,099
- No Clinical Signs, Symptoms or Conditions996
- Pain818
- No Consequences Or Impact To Patient764
Legacy2 Implant models
78 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Legacy™2 Implant 823710Implant, Endosseous, Root-Form768 reports
- Legacy™2 Implant 824710Implant, Endosseous, Root-Form618 reports
- Legacy™2 Implant 824210Implant, Endosseous, Root-Form556 reports
- Legacy™2 Implant 823711Implant, Endosseous, Root-Form530 reports
- Legacy™2 Implant 824211Implant, Endosseous, Root-Form386 reports
- Legacy™2 Implant 823713Implant, Endosseous, Root-Form383 reports
- Legacy™2 Implant 824708Implant, Endosseous, Root-Form366 reports
- Legacy™2 Implant 823210Implant, Endosseous, Root-Form351 reports
- Legacy™2 Implant 824711Implant, Endosseous, Root-Form292 reports
- Legacy™2 Implant 825210Implant, Endosseous, Root-Form279 reports
- Legacy™2 Implant 824213Implant, Endosseous, Root-Form278 reports
- Legacy™2 Implant 823708Implant, Endosseous, Root-Form272 reports
- Legacy™2 Implant 824208Implant, Endosseous, Root-Form256 reports
- Legacy™2 Implant 823211Implant, Endosseous, Root-Form235 reports
- Legacy™2 Implant 823213Implant, Endosseous, Root-Form199 reports
- Legacy™2 Implant 824713Implant, Endosseous, Root-Form197 reports
- Legacy™2 Implant 825710Implant, Endosseous, Root-Form162 reports
- Legacy™2 Implant 825208Implant, Endosseous, Root-Form150 reports
- Legacy™2 Implant 825211Implant, Endosseous, Root-Form150 reports
- Legacy™2 Implant 833710Implant, Endosseous, Root-Form114 reports
- Legacy™2 Implant 823208Implant, Endosseous, Root-Form1 death110 reports
- Legacy™2 Implant 825708Implant, Endosseous, Root-Form106 reports
- Legacy™2 Implant 833210Implant, Endosseous, Root-Form104 reports
- Legacy™2 Implant 823716Implant, Endosseous, Root-Form101 reports
- Legacy™2 Implant 834711Implant, Endosseous, Root-Form1 recall32 reports
- Legacy™2 Implant 834210Implant, Endosseous, Root-Form77 reports
- Legacy™2 Implant 834708Implant, Endosseous, Root-Form75 reports
- Legacy™2 Implant 827010Implant, Endosseous, Root-Form71 reports
- Legacy™2 Implant 825711Implant, Endosseous, Root-Form70 reports
- Legacy™2 Implant 834710Implant, Endosseous, Root-Form68 reports
- Legacy™2 Implant 834713Implant, Endosseous, Root-Form1 recall14 reports
- Legacy™2 Implant 825213Implant, Endosseous, Root-Form59 reports
- Legacy™2 Implant 833711Implant, Endosseous, Root-Form56 reports
- Legacy™2 Implant 834211Implant, Endosseous, Root-Form51 reports
- Legacy™2 Implant 827008Implant, Endosseous, Root-Form45 reports
- Legacy™2 Implant 824216Implant, Endosseous, Root-Form44 reports
- Legacy™2 Implant 833708Implant, Endosseous, Root-Form42 reports
- Legacy™2 Implant 825713Implant, Endosseous, Root-Form39 reports
- 38 reports
- Legacy™2 Implant 833713Implant, Endosseous, Root-Form38 reports
- Legacy™2 Implant 823216Implant, Endosseous, Root-Form33 reports
- Legacy™2 Implant 827013Implant, Endosseous, Root-Form30 reports
- Legacy™2 Implant 827011Implant, Endosseous, Root-Form26 reports
- 24 reports
- Legacy™2 Implant 834208Implant, Endosseous, Root-Form24 reports
- 23 reports
- Legacy™2 Implant 834213Implant, Endosseous, Root-Form22 reports
- Legacy™2 Implant 824716Implant, Endosseous, Root-Form19 reports
- Legacy™2 Implant 833716Implant, Endosseous, Root-Form19 reports
- Legacy™2 Implant 835210Implant, Endosseous, Root-Form19 reports
- Legacy™2 Implant 833208Implant, Endosseous, Root-Form17 reports
- 17 reports
- Legacy™2 Implant 833211Implant, Endosseous, Root-Form15 reports
- 14 reports
- Legacy™2 Implant 833213Implant, Endosseous, Root-Form14 reports
- Legacy™2 Implant 835710Implant, Endosseous, Root-Form14 reports
- 13 reports
- Legacy™2 Implant 833216Implant, Endosseous, Root-Form13 reports
- Legacy™2 Implant 835208Implant, Endosseous, Root-Form12 reports
- Legacy™2 Implant 835708Implant, Endosseous, Root-Form12 reports
- Legacy™2 Implant 825216Implant, Endosseous, Root-Form10 reports
- 10 reports
- Legacy™2 Implant 837008Implant, Endosseous, Root-Form9 reports
- 8 reports
- 8 reports
- Legacy™2 Implant 835711Implant, Endosseous, Root-Form8 reports
- Legacy™2 Implant 834716Implant, Endosseous, Root-Form7 reports
- Legacy™2 Implant 835211Implant, Endosseous, Root-Form7 reports
- Legacy™2 Implant 825716Implant, Endosseous, Root-Form5 reports
- Legacy™2 Implant 834216Implant, Endosseous, Root-Form4 reports
- 4 reports
- Legacy™2 Implant 835213Implant, Endosseous, Root-Form3 reports
- 3 reports
- Legacy™2 Implant 837011Implant, Endosseous, Root-Form3 reports
- Legacy™2 Implant 835713Implant, Endosseous, Root-Form2 reports
- Legacy™2 Implant 837013Implant, Endosseous, Root-Form2 reports
- Legacy™2 Implant 835216Implant, Endosseous, Root-Form1 report
- Legacy™2 Implant 837010Implant, Endosseous, Root-Form1 report
Recent Legacy2 Implant adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50952920 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50952909 ↗InjurySep 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50950797 ↗InjurySep 29, 2026Positioning Failure
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50938941 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935387 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935050 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934830 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934576 ↗InjurySep 29, 2026Positioning Failure
Lack of primary stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933031 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Clinical Complication only.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50917044 ↗InjurySep 17, 2026Positioning Failure
Lack of Primary Stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805277 ↗InjurySep 17, 2026Positioning Failure
Lack of Primary Stability.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804753 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780401 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 50780399 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inflammation; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 50780398 ↗
Other Implant Direct Sybron Manufacturing LLC products
- Legacy3 Implant75 models · 9,801 reports
- simply InterActive Implant23 models · 4,946 reports
- simply Legacy2 Implant38 models · 3,319 reports
- RePlant Implant20 models · 2,351 reports
- SIMPLY ICONIC Implant39 models · 2,189 reports
- Legacy4 Implant58 models · 1,786 reports
- Legacy1 Implant27 models · 1,635 reports
- InterActive Implant23 models · 1,609 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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