Z-1173-2016Class III

ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as...

Name: Z-1173-2016 ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as...
Creator: Collagen Matrix Inc
Published: 2015-11-17
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2015-11-17 / Terminated / root cause: design

FDA source

Collagen Matrix Inc began a recall of ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge... on 2015-11-17. FDA classified it as Class III and gives the reason as "The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1173-2016
Classification: Class III
Status: Terminated
Initiated: 2015-11-17
Posted: 2016-03-15
Terminated: 2018-05-10
Recalling firm: Collagen Matrix, Inc
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.
Product code: NPM Bone Grafting Material, Animal Source
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Collagen Matrix Inc. notified their sole customer on 11/17/2015.
Quantity in commerce: 200 units
Distribution: US in the state of TX
Product codes and lots: PMCS025 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A1 PMCS10 Lot No. PMCSU15A1 PMCS05 Lot No. PMCSU15A2 PMCS10 Lot No. PMCSU15A2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1173-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1173-2016	Class III	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-14

Product code NPM

K140714Class IIPorcine Anorganic Bone MineralCollagen Matrix, Inc. / cleared 2014-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)