🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: August 31, 2021 Medtronic Xomed Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    (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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Xomed, Inc.
Reason for Recall:
There was an increase in complaints related to tip breaks and wobble/vibration.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 Codes/Lot Numbers:

(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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0158-2022

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