Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm… recallZ-1174-2009 · Integra LifeSciences Corp. · initiated Mar 10, 2009
Terminated All recalls posted in April 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.
Recall details
- Recall number
- Z-1174-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 10, 2009
- Posted by the FDA
- Apr 7, 2009
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 125 units
- Product code
- FRO
- FDA submissions
- K021792
- Distribution
- Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.
Product description
Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.
Code information (models, lots, serial numbers)
Lot number 105BA0105205
Other devices under the same FDA submission
1 device cleared under K021792 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTEGRA® BMW2021Integra Lifesciences Corporation · Dressing, wound, drug1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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