RegenerOss Resorbable Xenograft ROXR40Recalls & reported problems
Collagen Matrix, Inc. · Porcine Anorganic Bone Mineral · Class 2 · Implant
All models of RegenerOss Resorbable Xenograft (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813954022369), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Oct 30, 2018Class IIITerminated
There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
Z-0752-2019 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Inflammation1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE CLINICIAN REPORTED HAVING ADVERSE EVENTS THAT THEY HAVE NOT SEEN IN THE PAST. THESE ADVERSE EVENTS INCLUDE BONE LOSS, DELAYED HEALING AND INFLAMMATION. IT IS UNKNOWN HOW THE CLINICIAN CIRCUMVENTED THE ISSUES.
Patient problems: Inflammation; No Code Available
MAUDE report 9106059 ↗
Other Bone Grafting Material, Animal Source devices
- NuOss 5091003Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE1 recall0 reports
- Gibson Healthcare® Bone Graft Plug 5824-413Collagen Matrix, Inc. · Bone Grafting Material, Animal Source6 reports
- OSSIX™ Bone 0.250 ccDatum Dental Ltd · Bone Grafting Material, Animal Source5 reports
- NuOss 5091004Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE5 reports
- PreservaRidge™ Plug PRPREGCollagen Matrix, Inc. · Bone Grafting Material, Animal Source3 reports
- NuOss 5099100Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE3 reports
- NuOss 5099002Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE3 reports
- NuOss 5099104Ace Surgical Supply CO., Inc. · BONE GRAFTING MATERIAL, ANIMAL SOURCE2 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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