Devices

DePuy Synthes

  • Model / Serial
    Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
  • Product Description
    Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
  • Manufacturer
    Synthes (USA) Products LLC
  • 1 Event

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

25 devices with a similar name

Learn more about the data here

DePuy Synthes Attune Intuition Distal Femoral Jig
  • Model / Serial
    Model: Part numbers: 254400521 and 254400520, Affected: All lots
  • Manufacturer
    DePuy Ireland UC
DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm
  • Model / Serial
    Model: 356.714, Affected: All lots
  • Manufacturer
    Synthes GmbH
DePuy Synthes S Cheek Retractor
  • Model / Serial
    Model: 397.232, Affected: Mulitple lot numbers
  • Manufacturer
    Synthes GmbH
DePuy Synthes Pedicle Awls, technique guides & outer labels
  • Model / Serial
    Model: 036.000.216, 036.001.185, 388.550, 388.656, Affected: All
  • Manufacturer
    Synthes GmbH
Device Recall DePuy Synthes Titanium Recon Screws
  • Model / Serial
    Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
  • Manufacturer
    Synthes, Inc.
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