Class 1 Device Recall microTargeting Insertion Tube Set

• Date Initiated by Firm: October 04, 2024
• Date Posted: November 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0312-2025
• Recall Event ID: 95479
• 510(K)Number: K011775
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: 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.
• Code Information: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
• Recalling Firm/ Manufacturer: FHC, Inc.; 1201 Main St; Bowdoin ME 04287-7302
• For Additional Information Contact: Kelly Moeykens; 207-666-5651
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 8 packs of 5ea (40 total)
• Distribution: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HAW