Device product
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Z-2082-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,159 units
- Official record key
device-enforcement:Z-2082-2023
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): 607-105-112 (10381780177685), 607-105-125 (10381780113591), 607-105-225 (10381780113607), 607-105-440 (10381780113614), 607-105-660 (10381780177715), 607-105-812 (10381780177739), 607-105-880 (10381780177722).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification