Device product
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Z-2083-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 199 units
- Official record key
device-enforcement:Z-2083-2023
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): 611-001-001 (10381780357292), 611-001-002 (10381780357278), 611-001-003 (10381780357285).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification