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Devices
HPlate
Model / Serial
Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot: a) (18056099647908) B1096740; b) (18056099647915) B1096733; c) (18056099647939) B1096734; d) (18056099647953) B1096735; e) (18056099647960) B1100226
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
H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): || a) 12MM Spacer (003-H-12001); || b) 15MM Spacer (003-H-15001); || 20MM Spacer (003-H-20001); || 25MM Spacer (003-H-25001); || 30 MM (003-H-30001)
Manufacturer
Orthofix, Inc
1 Event
Recall of HPlate
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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
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