Recall Weekly
FDA DeviceClass II

Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

Increased rate of out-of-specification endotoxin results.

From the FDA notice · Read the official notice ↗ · All Integra LifeSciences recalls

What to do

The agency's notice has the remedy and who to contact.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
452 units
Illnesses reported
None reported
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Classification
Class II
Recall number
Z-1818-2026

In the FDA's words

Description
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Increased rate of out-of-specification endotoxin results. Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 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: 452 units
Hazard
Increased rate of out-of-specification endotoxin results.

5 products in this recall

Integra Cytal wound and burn matrices recalled for endotoxin results

Integra LifeSciences is recalling five sizes of Cytal Wound Matrix and Cytal Burn Matrix products because an increased rate of endotoxin test results fell outside acceptable limits. The recall covers 879 units distributed across many US states. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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