Recall Z-0312-2025 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
| Date | Nov 8, 2024 (initiated Oct 4, 2024) |
| Status | Open, Classified |
| Reason | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage. |
| Root cause | Process change control |
| Action | On October 4, 2024, the firm notified affected consignees via Urgent Medical Device Recall letters. Customers were instructed to immediately identify and quarantine all affected product. The firm will contact customers and issue an RMA to return affected product and issue a replacement by 10/11/24. Customers should not use the product in the interim. Should you have any further questions regarding this matter you may contact the firm by email at kmoeykens@fh-co.com or by telephone at 207-666-5425. |
| Quantity | 8 packs of 5ea (40 total) |
| Distribution | Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011775 | MICRO TARGETING DRIVE SYSTEM FHC, Inc., Aug 30, 2001 |