Device product
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Z-2081-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,264 units
- Official record key
device-enforcement:Z-2081-2023
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): 607-104-125(10381780113775) , 607-104-225 (10381780113782), 607-104-440 (10381780113560), 607-104-660 (10381780113577), 607-104-812 (10381780113768), 607-104-880 (10381780113584).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification