Z-0158-2022Class II

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT...

Name: Z-0158-2022 Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT...
Creator: Medtronic Xomed, Inc.
Published: 2021-08-31
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2021-08-31 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Xomed, Inc. began a recall of Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw... on 2021-08-31. FDA classified it as Class II and gives the reason as "There was an increase in complaints related to tip breaks and wobble/vibration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0158-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-31
Posted: 2021-10-21
Recalling firm: Medtronic Xomed, Inc.
Product: 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, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: There was an increase in complaints related to tip breaks and wobble/vibration.
Root cause tag: manufacturing process
FDA 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 in commerce: 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, Iceland, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kuwait, Latvia, Libya, Luxembourg, Macao, Malaysia, Mauritius, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Viet Nam.
Product codes and lots: (1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825; (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458; (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192; (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459; (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674; (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669; (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602; (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633; (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618; (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193; (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0158-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0156-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-21
Z-0157-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-21
Z-0158-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-21

Product code HBE

K081475Class IIElectric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]Medtronic Xomed, Inc. / cleared 2008-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)