Collagen Matrix Inc recalls ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or rec…

Recall date

November 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1173-2016

FDA classification

Class III

Brand / firm

Collagen Matrix Inc

Sold / distributed

US in the state of TX

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.