—#197481

Product

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

FDA product code: GAD — Retractor
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI/Lot: 00763000432805/ 705F, 706F, 707F, 708F, 709F

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

On 11/17/22 customers were verbally notified to quarantine affected devices. On 12/08/22, recall notices were sent to customers asking them to take the following action: 1) Discontinue use of affected devices. 2) Return affected devices to the recalling firm. 3) Complete and return the customer confirmation form that can be emailed to neuro.quality@medtronic.com 3) The notice needs to be shared with all who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Customers with questions are encouraged to call/email: Medtronic Technical Services at 1-888-826-5603/rs.navtechsupport@medtronic.com

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

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.

Timeline

Recall initiated: 2022-12-08
Posted by FDA: 2023-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.