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Terminated

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

FDA Recall Z-2733-2016 · Posted 2016-09-02

Recalling FirmIntegra LifeSciences Corp. d.b.a. Integra Pain Management
Recall StatusTerminated
Product CodeHBG
Date Initiated2016-08-24
Date Terminated2017-03-30
Product Quantity710

Reason for Recall

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.

Firm Action

Consignees notified on August 12, 2016 via letter to identify and return product.

Root Cause

Packaging

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC · 1996-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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