OSSIX™ Bone 0.125 ccRecalls & reported problems

Datum Dental Ltd · OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. · Class 2 · Implant

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290015477215), received between Apr 23, 2025 and Apr 23, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Appears to Trigger Rejection1

Patient problems

Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION DURING A DENTAL PROCEDURE THAT INCLUDED THE USE OF OSSIX BONE, DENTSPLY ARTICAINE AND AMOXICILLIN. THE PATIENT ENDED UP IN EMERGENCY DEPARTMENT. THE DOCTOR REPORTED THAT THE PATIENT HAS HAD ANTIBIOTICS BEFORE WITHOUT ISSUE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21889706 ↗

Device details

UDI-DI	`07290015477215`
Brand	OSSIX™ Bone
Model	0.125 cc
Catalog no.	OXB0125
Company	Datum Dental Ltd
Product code	NPM · Bone Grafting Material, Animal Source
Class	Class 2
FDA submission	K163714
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 9, 2026

Device type (GMDN): Dental bone matrix implant, synthetic

A sterile bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

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All Bone Grafting Material, Animal Source devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.