Z-0025-2016Class II

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter...

Name: Z-0025-2016 Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter...
Creator: Integra LifeSciences Corp.
Published: 2015-08-21
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2015-08-21 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW... on 2015-08-21. FDA classified it as Class II and gives the reason as "Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0025-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-21
Posted: 2015-10-06
Terminated: 2016-10-13
Recalling firm: Integra LifeSciences Corporation
Product: Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Integra sent an Urgent-Voluntary Medical Device Recall letter dated August 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm instructed their customers to: 1. Review your inventory and determine if you have an UCHRAP Adapter Plate with an affected serial number listed on the next page. If you do not, it is not affected and you can continue to use it. 2. If you do have product with a serial number listed on the next page, stop using it immediately and remove it from service. 3. Complete the attached form. If you do not have product with a serial number listed, check the box, I do not have any product with a serial number on the list below. 4. If you do have product with a serial number listed, check the box, I do have product(s) with a serial number below. Circle the lot numbers and record the total quantity of all lot numbers you have. 5. Complete the other information and return it by email or fax as indicated on the form or by providing it to your Integra Neuro Specialist. If an Integra Neuro Specialist has not already done so, Customer Service will contact you and provide an RMA number and directions for returning and replacing the product. Should you have any questions regarding these instructions, please call : (513) 533-7932. For any other questions, please call (609) 936-6822.
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
Product codes and lots: Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0025-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0025-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)