Recall Z-1234-2016 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
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
| Date | Feb 22, 2016 |
| Status | Terminated |
| Reason | 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 | No Marketing Application |
| Action | 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 con |
| Quantity | 4 |
| Distribution | US Distribution to states of: FL, NJ, AZ, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003201 | STEALTHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation Technologies, Dec 12, 2000 |