FDA-Device2018-06-13Class II
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-2003
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
601
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-20030)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2119-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief