Device product
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Z-2079-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33,277 units
- Official record key
device-enforcement:Z-2079-2023
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): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-550 (10381780113454), 607-005-660 (10381780113461), 607-005-812 (10381780113478), 607-005-880 (10381780113485).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification