Device Recall RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM

  • Model / Serial
    Batch numbers:  431604,431612,431614,467087,469005,472361,477931,481940,485498,488987,490565,491378, 492345,4500032273,07LSY0034,07LSY0041,07MSY0013,08FSY0052,08LSY0020,08LSY0020A, 08LSY0042,08MSY0020,09BSY0030,11DSY0007,11ESY0011,11FSY0006,11HSY0013, 11HSY0060,11JSY0008,11JSY0019,12KSY0027,12MSY0008,12MSY0016,13BSY0036, 13FSY0026,13KSY0016,14GSY0013,14KSY0005,15ASY0020,15ESY0015,15JSY0009,15MSY0009, 16ESY0079,477931A,477931B,477931C,490565A,492345A
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
  • Product Description
    RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
  • Source
    USFDA