Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation
FDA device recall Z-0157-2022 · posted 2021-10-21 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- There was an increase in complaints related to tip breaks and wobble/vibration.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HAW
- Quantity affected
- 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,
- Date initiated
- 2021-08-31
- Date posted
- 2021-10-21
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUADCUT (K130608) | Medtronic Navigation, Inc. | 2013-08-07 |