Z-1187-2012

Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the...

Name: Z-1187-2012 Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the...
Creator: Integra LifeSciences Corp
Published: 2012-01-23
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-01-23 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp began a recall of Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the TomoTherapy HiArt (Torno) System The Integra InterFix... on 2012-01-23. The reason FDA records is "Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used...". 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-1187-2012
Status: Terminated
Initiated: 2012-01-23
Posted: 2012-03-08
Terminated: 2012-10-01
Recalling firm: Integra LifeSciences Corporation
Product: Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning and treatment with the TomoTherapy HiArt (Torno) System The Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation during CT and and treatment with the Tomo Therapy Hi-Art system. Provides adapters for attaching: Integra head rings to the following: 1.Flat CT scanner tabletops ranging form 47cm to 54 cm 2. TomoTherapy Hi-Art system tabletop
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree TomoTherapy arc.
Root cause tag: design
FDA root cause: Device Design
Action: Integra sent a Product Technical Bulletin dated January 23, 2012, to all affected consignees via FedEx, email or telephone conference calls. The revised Operator Manual was provided with a Technical Bulletin to all consignees that have been shipped this system. Consignees were asked to distribute the information in the bulletin to members of the Radiotherapy Planning Team within their institution. Customers were also asked to sign and return the enclosed Product Technical Bulletin Acknowledgement Form. For questions regarding this recall call 888-772-7378.
Quantity in commerce: 33 units
Distribution: Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
Product codes and lots: Lot Number: 113820 114121 114430 114586 117771 121402 130169 131122 133760 133810 135008 135429 135429 141074 141563 143905 143905 148028 154133 155785 161426 166069 168862 172321 172321 182007 186253 189940 195330 195330 237711 2 units no lot number identified

Product code IYE

K072454Class IIIntegra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. / cleared 2007-10-16

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)