ZCORE Porcine Xenograft Particulate in Syringe Product Intended for… — Class III medical device recall Z-1173-2016
Terminated recall by Collagen Matrix Inc, reported 2016-03-23, distributed in TX. The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the
| Recall number | Z-1173-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Collagen Matrix Inc, Franklin Lakes, NJ, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2016-03-14 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2018-05-10 |
| Distributed | TX |
| Quantity | 200 units |
| Lot numbers | PMCS05, PMCS10, PMCSU15A1, PMCSU15A2 |
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 for recall
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1173-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.