FDAFDA · Food and drugs·Recall number Z-1173-2016
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.
Published March 23, 2016 · Recall initiated: November 17, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Collagen Matrix Inc
- Distributor
- US in the state of TX
- Lot
- PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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