Recall Z-2733-2016— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-2733-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-24

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2016-08-24, terminated 2017-03-30. It names one FDA 510(k) clearance: K961113. Product: Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND. 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..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Terminated: 2017-03-30
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC·cleared 1996-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.