Device product
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Z-2075-2023
Product summary
- Event
- Event 92481
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,664 units
- Official record key
device-enforcement:Z-2075-2023
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): 606-400-002 (10381780113201), 606-400-004 (10381780113218), 606-400-006 (10381780113225), 606-400-009 (10381780113232), 606-400-016 (10381780113249), 606-400-017 (10381780113256), 606-400-018 (10381780113263), 606-403-001 (10381780113270), and 606-404-001 (10381780113287).
Distribution pattern: Domestic: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification