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Recall Observatory FDA recall evidence

Device product

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Z-0953-2023

December 08, 2022

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 91328
Status
Ongoing
Classification
Class II
Quantity
2317
Official record key
device-enforcement:Z-0953-2023

Official wording

Reason: Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Code information: UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Distribution pattern: US Nationwide distribution including in the states of OH, CA, FL, NJ, NY, MN, IN, VA, WA, MS, SC, MO, GA, PA, KS, TN, LA, TX, ME, MA, AL, NC, MD, NH, IL, AZ, MI, NV, MT, OK, SD, RI, CO, CT, NM, NE, DE, WI.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination, which can lead
  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch seal, incomplete
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile pouch seal, incomplete