Universal Compact Head Ring Adapter Plate (UCHRAP), a… recallZ-0025-2016 · Integra LifeSciences Corp. · initiated Aug 21, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0025-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 21, 2015
- Posted by the FDA
- Oct 6, 2015
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 6 units
- Product code
- HAW
- FDA submissions
- K944463
- Distribution
- Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.
Product description
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.
Code information (models, lots, serial numbers)
Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906
Other devices under the same FDA submission
2 devices cleared under K944463 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CRW® HRAIMIntegra Lifesciences Corporation · Neurological stereotaxic Instrument1 report
- Integra® UCHRAIntegra Lifesciences Corporation · Neurological stereotaxic Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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