Recall Z-1173-2016— Collagen Matrix Inc

Name: FDA recall Z-1173-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-17

Class III · Terminated

Class III FDA medical device recall by Collagen Matrix Inc, initiated 2015-11-17, terminated 2018-05-10. It names one FDA 510(k) clearance: K140714. Product: 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: The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine..

Recalling firm: Collagen Matrix Inc
Classification: Class III
Status: Terminated
Initiated: 2015-11-17
Terminated: 2018-05-10
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K140714 — PORCINE ANORGANIC BONE MINERALCollagen Matrix, Inc.·cleared 2014-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.