Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gentrix Surgical Matrix Thick Recalled by ACell, Inc Due to The devices were released from a lot for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ACell, Inc directly.
Affected Products
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
Quantity: 1
Why Was This Recalled?
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ACell, Inc
ACell, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report