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Recall Observatory FDA recall evidence

Device product

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

Z-2733-2016

August 24, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Event
Event 75028
Status
Terminated
Classification
Class II
Quantity
710
Official record key
device-enforcement:Z-2733-2016

Official wording

Reason: 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.

Code information: Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12

Distribution pattern: Nationwide and VA/govt/military. No foreign consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.