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Terminated

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.

FDA Recall Z-1173-2016 · Posted None

Recalling FirmCollagen Matrix Inc
Recall StatusTerminated
Product CodeNPM
Date Initiated2015-11-17
Date Terminated2018-05-10
Product Quantity200 units

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.

Firm Action

Collagen Matrix Inc. notified their sole customer on 11/17/2015.

Root Cause

Component design/selection

Distribution Pattern

US in the state of TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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