Device Recall EXACTECH

Manufacturer

  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
  • Product Description
    Equinoxe 44mm Short Humeral Head || Catalog Number 310-01-44. || Orthopedic shoulder implant component.
  • Manufacturer
  • Model / Serial
    Catalog Number 28202, Lot Number AS05107
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of FL, GA, IL, NY, TX, and WA.
  • Product Description
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. || Intended to provide immobilization and stabilization of spinal segments.
  • Manufacturer
  • Model / Serial
    Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-007, 51825-006, 52224-005, 52224-006, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 75153-001, and 74999-001.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom
  • Product Description
    Exactech 1.5" Novation Calcar Planer Guide Tip || To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. || ech 1.5" Novation Calcar Planer Guide Tip
  • Manufacturer
  • Model / Serial
    All Lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
  • Product Description
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
  • Manufacturer
  • Model / Serial
    Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
  • Product Description
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
  • Manufacturer
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