Device product
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Z-1818-2026
Product summary
- Event
- Event 98607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 452 units
- Official record key
device-enforcement:Z-1818-2026
Official wording
Reason: Increased rate of out-of-specification endotoxin results.
Code information: Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.
Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
Derived failure modes
-
Potency or specification failure
out-of-specification