Device product
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Z-2080-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,689 units
- Official record key
device-enforcement:Z-2080-2023
Official wording
Reason: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Code information: Item No. (UDI-DI): 607-101-112 (10381780113492), 607-101-125 (10381780113508), 607-101-225 (10381780113515), 607-101-440 (10381780113522), 607-101-660 (10381780113539), 607-101-812 (10381780113546), 607-101-880 (10381780113553).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification