Z-2428-2012Class II

Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation...

Name: Z-2428-2012 Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation...
Creator: Integra LifeSciences Corporation
Published: 2012-08-09
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-08-09 / Terminated / root cause: design

FDA source

Integra LifeSciences Corporation began a recall of Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in... on 2012-08-09. FDA classified it as Class II and gives the reason as "T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2428-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-09-20
Terminated: 2014-03-26
Recalling firm: Integra LifeSciences Corporation
Product: Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Integra, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" dated August 10, 2012 to US & Canada consignees/customers via traceable courier service and Non-US & Non-Canada consignees/customers - through written notification delivered either by traceable courier, email, facsimile, or through a directed visit by an Integra Sales Representative. The notification describes the product, problem and actions to be taken. The Integra sales representative will replace the screws according to the attached rework instructions. If for some reason it is not possible to replace the screws during the visit, the sales representative will leave the screws and customers can then replace them by following the attached rework instructions and discard the old screws immediately after replacement. The customers were instructed to complete and return the Product Recall Acknowledgement Form via the sales representatives visit; fax at 1-609-750-7999 or email to: [email protected] and include the number of devices to be identified and replaced . Note:The T -Handle screws that are replaced will be disposed of at the consignee's/customers location. Please feel free to contact our service hotline at 888-772-7378 should you have any additional questions.
Quantity in commerce: 175 units
Distribution: Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
Product codes and lots: All lot numbers from 2002 to current

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2428-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2428-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2429-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code HAW

K944463Class IICrw-1 SystemRadionics Software Applications, Inc. / cleared 1995-10-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)