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Recall Observatory FDA recall evidence

Device product

RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)

Z-1914-2017

March 30, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76943
Status
Terminated
Classification
Class II
Quantity
8067 units
Official record key
device-enforcement:Z-1914-2017

Official wording

Reason: The stability data does not support the product labeled with a 10-year shelf life.

Code information: 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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The stability data does not support the product labeled with a 10-year shelf life.