—#143908

Product

BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K003201
Affected lot / code info: The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.

Why it was recalled

Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.

Root cause (FDA determination)

No Marketing Application

Action the firm took

The firm, Medtronic, sent an "URGENT Medical Device Recall" letter dated 2/2016 to its consignees. The letter described the product, problem and actions to be taken. The identified consignees will be visited by the assigned Medtronic field representative to explain the need for the field action. The consignees are instructed to locate and remove/secure the kit from use. The Medtronic field representative will assist the consignee with identifying and removing the kit, and complete a Customer Visit record for each consignee they are assigned/visit to document the results of their visit. The consignee is instructed to sign the customer visit form presented by the representative. A copy of this record and a letter explaining the FCA will be left with the consignee. Please contact Medtronic Technical Services at 1-800-595-9709 if you have any questions regarding the subject action or the content of the letter.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: US Distribution to states of: FL, NJ, AZ, and NC.

Timeline

Recall initiated: 2016-02-22
Terminated: 2016-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143908. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.