Mem-Lok RCM-ML2030Recalls & reported problems
Collagen Matrix, Inc. · Resorbable Collagen Membrane for Dental Surgery 20mm x 30mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813954020754), received between Dec 15, 2025 and Mar 3, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Insufficient Device Problem Information
A COMPLAINT REGARDING MEM-LOK RESORBABLE COLLAGEN MEMBRANE STATING "GRAFT FAILED AT IMPLANT SITE #2 AND #30 DUE TO INFECTION. PATIENT CARE RESOLVED BY INSERTING A NEW GRAFT". NO OTHER INFORMATION REGARDING PATIENT STATUS HAS BEEN PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 24497509 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS ADVERSE EVENT OCCURRED OUTSIDE OF THE U.S. HOWEVER, AS THERE IS A SIMILAR MARKETED DEVICE IN THE U.S., AN MDR IS BEING FILED. AT THE TIME OF COMPLAINT INITIATION, LIMITED INFORMATION WAS PROVIDED. CUSTOMER STATED THE MEM-LOK RESORBABLE COLLAGEN MEMBRANE WAS USED ON A PATIENT ON (B)(6) 2023. THE PATIENT RETURNED ON (B)(6) 2023 AND THE PRODUCT MATERIAL HAD RESORBED. THE PATIENT WAS PRESCIRBED MEDICATION - TYPE OF MEDICATION NOT SPECIFIED. FURTHER INFORMATION WAS PROVIDED, WHERE THE CUSTOMER CLARIFIED THE PATIENT WAS PRESCRIBED ANTIBIOTICS (TYPE OF ANTIBIOTICS NOT SPECIFIED) BEFORE AND AFTER THE PROCEDURE. THERE WERE NO NOTABLE COMPLICATIONS DURING THE INITIAL PROCEDURE. REVISION SURGERY WAS PERFORMED IN WHICH THE IMPLANTS WERE EXTRACTED AND THE DEFECT WAS COVERED AGAIN WITHOUT ANY AUGMENTATION. NO ADDITIONAL PROCEDURES WERE PLANNED. ADDITIONAL INFORMATION SURROUNDING THE PATIENT STATUS, PATIENT OUTCOME, AND EVENT DETAILS WERE REQUESTED BUT NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23812070 ↗
Other Barrier, Animal Source, Intraoral devices
- GIBSON HEALTHCARE 5303-235Benco Dental Supply CO. · Barrier, Animal Source, Intraoral2 recalls0 reports
- GIBSON HEALTHCARE 5303-226Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-306Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-342Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- GIBSON HEALTHCARE 5303-324Benco Dental Supply CO. · Barrier, Animal Source, Intraoral1 recall0 reports
- Neomem N1520Collagen Matrix, Inc. · Barrier, Animal Source, Intraoral1 recall0 reports
- BioMend 0103ZCollagen Matrix, Inc. · Barrier, Animal Source, Intraoral4 reports
- CopiOs Extend 0191ZCollagen Matrix, Inc. · Barrier, Animal Source, Intraoral3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.