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# Collagen Matrix Zcore Syringe Device Adulterated: FDA
- URL: https://www.fdaweb.com/collagen-matrix-zcore-syringe-device-adulterated-fda/
- Published: 2016-10-04T12:00:00.000Z
- Updated: 2026-09-14T21:36:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136974

A 11/9-11/25/15 FDA inspection at Collagen Matrix in Oakland and Franklin Lakes, NJ, found that the firm’s Zcore porcine xenograft particulate in syringe device is adulterated because it doesn’t comply with Quality System Regulations covering current good manufacturing practice. A 9/20 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm522402.htm?ref=fdaweb.com) from the agency’s New Jersey District Office says that the company failed to adequately conduct design validation to ensure that the device conforms to defined user need and intended uses.

The inspection also determined that the firm does not have an approved PMA in effect for the Zcore device. And the device is misbranded in that the company did not notify FDA of its intent to introduce the device into commercial distribution with significant design changes that were made since its initial 510(k) clearance.

The firm’s response to the inspection finding was inadequate, the letter says, because it did not include documentation showing that promised corrections have been made. Collagen Matrix was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken, with documentation of each corrective action and a timetable for completion.