Z-2733-2016Class II

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

Name: Z-2733-2016 Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2016-08-24
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2016-08-24 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND on 2016-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2733-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-09-02
Terminated: 2017-03-30
Recalling firm: Integra Pain Management
Product: Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Consignees notified on August 12, 2016 via letter to identify and return product.
Quantity in commerce: 710
Distribution: Nationwide and VA/govt/military. No foreign consignees.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2733-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2733-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code HBG

K961113Class IICns Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC / cleared 1996-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)