Warning
Integra LifeSciences Corp. (NeuroSciences) Recalls Cytal Wound Matrix 2-Layer 5x5 cm
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1816-2026Medical Device
Integra LifeSciences Corp. (NeuroSciences) Recalls Cytal Wound Matrix 2-Layer 5x5 cm
Integra LifeSciences Corp. (NeuroSciences) · Class II — Moderate Risk
Product Description
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Reason for Recall
Increased rate of out-of-specification endotoxin results.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database