Recall Z-0158-2022 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Medtronic Xomed, Inc.
Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000,
| Date | Oct 21, 2021 (initiated Aug 31, 2021) |
| Status | Open, Classified |
| Reason | There was an increase in complaints related to tip breaks and wobble/vibration. |
| Root cause | Process control |
| Action | The recalling firm issued letters dated 8/13/2021 on 8/31/2021 via USPS. The letter explained the reason for recall, risk to patient, and the actions to be taken. The consignee was requested to review their inventory of Medtronic blades against the list of affected products enclosed with the letter and to quarantine them. All unused, affected devices are to be returned to Medtronic by completing the Customer Confirmation form and returning it via FAX or email. Once completed, Customer Care will provide return instructions and issue a replacement for the returned product. |
| Quantity | 274,991 total devices |
| Distribution | Worldwide distribution - US Nationwide, including PR. There was also government/military distribution and the countries of Australia, Austria, Bahrain, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Icela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] Medtronic Xomed, Inc., Oct 17, 2008 |