Z-1173-2016 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2016
- Initiation Date
- November 17, 2015
- Termination Date
- May 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code Information
PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2