Devices

Device Recall RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH

  • Model / Serial
    Batch numbers:  472439,472579,472580,477931,482918,493639,11150707,4357136921,4500027315,4500030673, 4500032565,07AM06944,07LSY0047,07LSY0048,08BSY0012,08BSY0014B,08BSY0016, 08FSY0051,08JSY0012,08JSY0033,08KSY0015,08KSY0018,08LSY0011,08LSY0044,08LSY0044A, 08MSY0018,09BSY0011,09BSY0025,09DSY0012,09DSY0014,09FSY0005,09HSY0002,09HSY0006, 09HSY0006A,09JSY0002,09JSY0005,09JSY0006,09JSY0007,09JSY0008,09JSY0009,09KSY0002, 10CSY0003,10CSY0013,10CSY0014,10ESY0012,10ESY0017,10GSY0006,10HSY0007,10MSY0007, 11ASY0004,11ASY0008,11CSY0014,11DSY0002,11DSY0012,11ESY0006,11FSY0003,11FSY0004, 11GSY0002,11GSY0019,11GSY0020,11HSY0016,11HSY0023,12CSY0004,12DSY0024,12DSY0027, 12FSY0025,12HSY0006,12HSY0021,12HSY0035,12KSY0021,12LSY0017,12MSY0003,12MSY0011, 13BSY0006,13BSY0012,13BSY0038,13BSY0039,13ESY0006,13FSY0016,13HSY0003,13HSY0006, 13HSY0007,13KSY0047,13MSY0002,14ASY0033,14BSY0011,14CSY0004,14CSY0033,14DSY0013, 14DSY0015,14GSY0018,14HSY0005,14HSY0011,14KSY0002,14LSY0009,15ASY0013,15BSY0008, 15CSY0006,15ESY0024,15FSY0018,15FSY0061,15JSY0003,15KSY0036,15MSY0004,16ASY0006, 16BSY0012,16DSY0023,16ESY0078,16FSY0007,16JSY000516KSY0007,472580B
  • Product Classification
    General and Plastic Surgery Devices
  • 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, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
  • Manufacturer
    Smith & Nephew, Inc.
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH
  • Model / Serial
    Batch numbers:  452406,455856,456888,467087,469005,477931,483890,485094,485498,492100,492345,4500028121, 4500029102,4500032565,07MSY0025,08CSY0040,08FSY0036,08JSY0001,08JSY0010,08JSY0010A, 08JSY0031,08JSY0031A,08KSY0009,08LSY0005,08LSY0021,08LSY0022,08MSY0004,09BSY0028, 09HSY0009,10CSY0010,10CSY0021,10CSY0022,10ESY0010,10ESY0018,10KSY0034,11CSY0010, 11DSY0005,11DSY0013,11DSY0050,11ESY0009,11FSY0005,11GSY0008,11GSY0027,11HSY0011, 11HSY0059,11JSY0005,12ASY0015,12BSY0016,12DSY0017,12ESY0002,12FSY0004,12GSY0031, 12HSY0027,12HSY0043,12KSY0026,12MSY0006,12MSY0028,13BSY0017,13BSY0034,13ESY0007, 13FSY0025,13JSY0023,13KSY0012,13LSY0012,14BSY0001,14BSY0025,14CSY0041,14GSY0020, 14HSY0013,14KSY0004,14KSY0032,14LSY0016,15ASY0017,15ASY0019,15ASY0024,15CSY0008, 15DSY0003,15ESY0013,15FSY0021,15HSY0006,15JSY0010,15KSY0038,15MSY0007,16ASY0008, 16BSY0015,16ESY0080,496187A
  • Product Classification
    General and Plastic Surgery Devices
  • 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, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
  • Manufacturer
    Smith & Nephew, Inc.