NuOssRecalls & reported problems across all models
Ace Surgical Supply CO., Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NuOss model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 1
We found 6 models of NuOss by Ace Surgical Supply CO., Inc. in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2017 and Mar 18, 2022 — classified as 11 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
NuOss 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.
- Feb 2, 2022Open, Classified
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Z-0823-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported NuOss problems
Device problems
- Failure to Osseointegrate8
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem3
- Inaccurate Information1
- Patient-Device Incompatibility1
Patient problems
- Inadequate Osseointegration5
- Complaint, Ill-Defined4
- Failure of Implant3
- Inflammation3
- Post Operative Wound Infection3
- No Clinical Signs, Symptoms or Conditions1
NuOss models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NuOss 5091003BONE GRAFTING MATERIAL, ANIMAL SOURCE1 recall0 reports
- NuOss 5091004BONE GRAFTING MATERIAL, ANIMAL SOURCE5 reports
- NuOss 5099002BONE GRAFTING MATERIAL, ANIMAL SOURCE3 reports
- NuOss 5099100BONE GRAFTING MATERIAL, ANIMAL SOURCE3 reports
- NuOss 5099104BONE GRAFTING MATERIAL, ANIMAL SOURCE2 reports
- NuOss 5099250BONE GRAFTING MATERIAL, ANIMAL SOURCE1 report
Recent NuOss adverse event reports
The 14 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 18, 2022Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE INCORRECT PRODUCT WAS IN THE BOX. AS PER THE DISTRIBUTOR'S REPRESENTATIVE FROM THE REPORTING FACILITY, THEY STATED TWO PATIENTS WERE TREATED WITH THE MISLABELED PRODUCT, COLLATENE FIBRILLAR COLLAGEN RATHER THAN NUOSS COLLAGEN BLOCK. A HHE CONDUCTED BY THE DISTRIBUTOR AND COLLAGEN MATRIX CONFIRMED THE HEALTH RISK IS LOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13806244 ↗InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.
Patient problems: Post Operative Wound Infection
MAUDE report 11286359 ↗InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.
Patient problems: Post Operative Wound Infection
MAUDE report 11286357 ↗InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THEY HAD A PATIENT THAT WAS PRESENTED WITH PAIN, REDNESS, AND SWELLING IN THE AREA AFTER SURGERY. REVISION INCLUDED RE-ENTERING THE SURGICAL SITE, REMOVING THE INFECTED TISSUE, BONE, AND BIOCERAMIC PUTTY, THOROUGHLY CLEANING THE AREA WITH CHLORHEXIDINE GLUCONATE. PLACING NEW BIOCERAMIC PUTTY IN THE TOOTH ACCESS, PLACING NEW BONE, AND CLOSING THE SITE WITH SUTURE. PATIENTS WERE PLACED ON AN ANTIBIOTIC AND CHLORHEXIDINE GLUCONATE REGIMEN 2 DAYS PRIOR TO TREATMENT AND 5 DAYS FOLLOWING TREATMENT.
Patient problems: Post Operative Wound Infection
MAUDE report 11286350 ↗MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT THERE WAS NO BONE INTEGRATION FOLLOWING THE BONE GRAFT PROCEDURE. A FOLLOW-UP PROCEDURE WAS PERFORMED TO REMOVE THE PRODUCT AND RE-GRAFT THE SITE WITH ANOTHER BONE GRAFT PRODUCT WHICH RESULTED IN A 4-6 MONTH DELAY IN IMPLANT PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 7834351 ↗MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT THE PATIENT UNDERWENT A BONE GRAFT PROCEDURE AND OBSERVED NO INTEGRATION. THE MATERIAL APPEARED DISCOLORED AND DARKER IN SHADE. NO INFECTION WAS OBSERVED. THE CLINICIAN PERFORMED A FOLLOW-UP PROCEDURE TO REMOVE THE ORIGINAL BONE GRAFT AND RE-GRAFTED THE SITE USING ANOTHER PRODUCT. THERE WAS A DELAY IN PLACEMENT OF IMPLANT 4 TO 6 MONTHS.
Patient problems: Failure of Implant
MAUDE report 7834348 ↗MalfunctionAug 30, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT THERE WAS NO BONE INTEGRATION FOLLOWING THE BONE GRAFT PROCEDURE. A FOLLOW-UP PROCEDURE WAS PERFORMED TO REMOVE THE PRODUCT AND RE-GRAFT THE SITE WITH ANOTHER BONE GRAFT PRODUCT WHICH RESULTED IN A 4-6 MONTH DELAY IN IMPLANT PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 7834346 ↗InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.
Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration
MAUDE report 7178438 ↗InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE. ADDITIONALLY, THE PATIENT PRESENTED WITH UNRESOLVED SUBMANDIBULAR GLAND LYMPHADENOPATHY AND FLOOR OF MOUTH SWELLING AND WAS REFERED TO ENT PHYSICIAN.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 7178437 ↗InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.
Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration
MAUDE report 7178436 ↗InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.
Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration
MAUDE report 7178432 ↗InjuryJan 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR STATED THAT AFTER NOTICING THE BONE QUALITY WAS NOT WHAT THE DOCTOR WAS USED TO SEEING, THE PATIENT RETURNED BACK TO THE OFFICE WHERE THE NUOSS FELL OUT OF ITS GRAFT SITE. SUBSEQUENT TO THE REQUEST FOR ADDITIONAL FEEDBACK, THE CLINICIAN STATED THAT FOLLOWING RIDGE PRESERVATION PROCEDURE AN UNSPECIFIED EMERGENCY EVENT OCCURRED DURING THE HEALING PROCESS. AT THE TIME LOOSE, UNINCORPORATED NUOSS PARTICLES WERE FOUND IN THE SITE.
Patient problems: Complaint, Ill-Defined; Inadequate Osseointegration
MAUDE report 7178425 ↗InjuryDec 27, 2017Patient-Device Incompatibility
PATIENT EXPERIENCED SWELLING WITHIN 24 HOURS OF PROCEDURE, NO INFECTION WAS OBSERVED. THE PATIENT RECEIVED ANTIBIOTICS, PAIN MEDICATION AND MOUTHWASH. THE SYMPTOMS SUBSIDED WITHIN 1 WEEK.
Patient problems: Inflammation
MAUDE report 7148264 ↗InjuryDec 27, 2017Insufficient Device Problem Information
PATIENT EXPERIENCED SWELLING WITHIN 24 HOURS OF PROCEDURE, NO INFECTION WAS OBSERVED. THE PATIENT RECEIVED ANTIBIOTICS, PAIN MEDICATION AND MOUTHWASH. THE SYMPTOMS SUBSIDED WITHIN 1 WEEK.
Patient problems: Inflammation
MAUDE report 7148262 ↗
Other Ace Surgical Supply CO., Inc. products
All Ace Surgical Supply CO., Inc. devices →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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