Reported May 22, 2013 · Terminated
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion…
Integra LifeSciences Corporation
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: Integra LifeSciences Corporation · 105 Morgan Ln · Plainsboro, NJ · 08536-3339
Is this the product you have?
- Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
- Lot codes and dates
- 1125812 1125816 1126021
- Amount recalled
- 215 boxes
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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