Devices

Device Recall ZCORE Syringe

Model / Serial
PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2
Product Classification
Dental Devices
Device Class
2
Implanted device?
Yes
Distribution
US in the state of TX
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.
Manufacturer
Collagen Matrix Inc
1 Event
- Recall of Device Recall ZCORE Syringe

Manufacturer

Collagen Matrix Inc

Manufacturer Address
Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
Manufacturer Parent Company (2017)
Collagen Matrix Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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