ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such...

FDA Device Recall #Z-1173-2016 — Class III — November 17, 2015

Recall Summary

Recall Number Z-1173-2016
Classification Class III — Low risk
Date Initiated November 17, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Collagen Matrix Inc
Location Franklin Lakes, NJ
Product Type Devices
Quantity 200 units

Product Description

ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -Filling of periodontal defects in conjunction with products -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Reason for Recall

The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.

Distribution Pattern

US in the state of TX

Lot / Code Information

PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2

Other Recalls from Collagen Matrix Inc

Recall # Classification Product Date
Z-1777-2022 Class II Collagen Dental Wound Dressing - Bovine Dermis ... Aug 3, 2022
Z-0911-2020 Class II GIBSON Healthcare Membrane Extended, 20mm x 30m... Nov 5, 2019
Z-0910-2020 Class II GIBSON Healthcare Membrane Extended, 15mm x 20m... Nov 5, 2019
Z-0907-2020 Class II GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Re... Nov 5, 2019
Z-0909-2020 Class II GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Re... Nov 5, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.