—#139703

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K944463
Affected lot / code info: Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.

Timeline

Recall initiated: 2015-08-21
Posted by FDA: 2015-10-06
Terminated: 2016-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.