Collagen Matrix Recalls ZCORE Porcine Xenograft Syringes for Malfunction
Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe because the syringes were not working properly.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a mechanical malfunction (syringes not working) rather than a biological hazard.
Plain-English summary
Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe. The product is intended for use in dental surgery, including alveolar ridge augmentation, filling of extraction sockets, and sinus floor elevation. The recall covers specific lots PMCSU15A1 and PMCSU15A2 in various package sizes (PMCS025, PMCS05, and PMCS10).
The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly. As a result, the syringes were held in quarantine. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected units were distributed in Texas. Patients or healthcare providers who have received this product should contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- 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 pres
- Manufacturer
- Collagen Matrix Inc
- Hazard
- Affected units
- 200
Distribution
Distributed in 1 state:
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