Z-0953-2023 Class II Ongoing
FDA device recall Z-0953-2023 was initiated by Medtronic Navigation, Inc. on December 8, 2022 and is designated Class II. Reason for recall: Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. The recall status is ongoing. Affected quantity: 2317.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- December 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2317
Product Description
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Reason for Recall
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
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.
Code Information
UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F