Medicrea International: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intellig

Hazard

Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

Details from the source

Reason for recall: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification. Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Argentina Australia Belgium Brazil Bulgaria Chile Czech Republic Denmark Finland France Germany Greece Iceland Ireland Israel Italy Luxembourg Malaysia Mexico Monaco Morocco Netherla Quantity: 1,548 users Lot/code info: UNiD HUB is not a medical device and thus does not have a CFN or GTIN code. UNiD Spine Analyzer Product Number SW3002 UDI-DI code: 03613720286929 No lot numbers

UPC codes

03613720286929

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.