FDA-Device2026-04-22Class II
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Integra LifeSciences Corp. (NeuroSciences)
Hazard
Increased rate of out-of-specification endotoxin results.
Sold states
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.
Affected count
46 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2026Original summary
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Increased rate of out-of-specification endotoxin results. Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013. Distribution: 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. Affected quantity: 46 units
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