Device product
TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.
Z-2085-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,832
- Official record key
device-enforcement:Z-2085-2023
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): 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), 6495-9-006 (10381780113645).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification