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Devices
Evans Plate
Model / Serial
Lot: B1212604, Date of Manufacture: 2017-11-15, Use By: 2022-10-15, UDI: a) (18056099647724) B1099059, B1123627; b) (18056099647731) B1099057; c) (18056099647748) B1099068; d (18056099647755) B1099069
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Product Description
Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); || b) 8MM Spacer (022-H-00008); || c) 10MM Spacer (002-H-00010); || d) 12MM Spacer (002-H-00012)
Manufacturer
Orthofix, Inc
1 Event
Recall of Evans Plate
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Manufacturer
Orthofix, Inc
Manufacturer Address
Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
Manufacturer Parent Company (2017)
Orthofix International Nv
Source
USFDA
Language
English
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