Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

Recall date

August 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2733-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Sold / distributed

Nationwide and VA/govt/military. No foreign consignees.

Why it was recalled

Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND