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U.S. Department of Health and Human Services

Class 2 Device Recall Cytal Wound Matrix 2Layer 7x10 cm

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 Class 2 Device Recall Cytal Wound Matrix 2Layer 7x10 cmsee related information
Date Initiated by FirmMarch 19, 2026
Date PostedApril 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1817-2026
Recall Event ID 98607
510(K)NumberK152721 
Product Classification Wound dressing with animal-derived material(s) - Product Code KGN
ProductCytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Code Information Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013.
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactSajeel Afzal
1-640-2619909
Manufacturer Reason
for Recall		Increased rate of out-of-specification endotoxin results.
FDA Determined
Cause 2		Under Investigation by firm
ActionIntegra LifeSciences notified consignees on about 03/19/2026 via letter. Consignees were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Consignees were also instructed to forward to all affected personnel who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas. Distributors were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Distributors were also instructed to check customer traceability records and notify them if they have any shipments with affected units. They requested to modify the acknowledgement form to provide to customers, collect completed response forms and provide those numbers in the distributor reply form. Integra LifeSciences sent a second notification letter on about 03/20/2026, which updated the lot numbers affected. Consignees were asked to disregard the previous letter and replace it with the updated one. Directions for consignees and distributors did not change.
Quantity in Commerce46 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KGN
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