Reported Mar 27, 2019 · Terminated
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix…
ACell, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ACell, Inc · 6640 Eli Whitney Dr Ste 200 · Columbia, MD · 21046-2626
Is this the product you have?
Gentrix Surgical Matrix Thick20 x 30cmCatalog Number PSMT2030
- Lot 013948 - Product UsageGentrix 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 procedureshernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair
- Lot codes and dates
- SN KJ000423
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- CA
Why it was recalled
The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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