Device Recall 1.5 mm RAPIDSORB Rapid Resorbable Orbital Floor Plates with Bending Template Sterile

  • Model / Serial
    Catalog # 851.689.01S, Lot # 7672066 and 7672089
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
  • Product Description
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. || Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog # 851.690.01S, Lot # 6904416, 6904418, 7672126
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
  • Product Description
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. || Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
  • Manufacturer
  • Model / Serial
    Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
  • Product Description
    1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. || Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
  • Manufacturer