FDA-Device2018-06-13Class II
TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
Orthofix, Inc
Hazard
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Sold states
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Affected count
24
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2018Don't want to check this manually?
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