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Recall Observatory FDA recall evidence

Device product

RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)

Z-1910-2017

March 30, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76943
Status
Terminated
Classification
Class II
Quantity
1416 units
Official record key
device-enforcement:Z-1910-2017

Official wording

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

Code information: Batch numbers: 431612,433667,448956,466339,469005,473044,473406,477931,484324,485498,4500029102, 4500032273,07LSY0028,07MSY0023,07MSY0027,08CSY0051,08CSY0055,08CSY0055A, 08JSY0032,08LSY0052,09BSY0018,09BSY0027,10GSY0007,11ASY0006,11DSY0048,11FSY0009, 11GSY0005,11HSY0008,11JSY0011,11MSY0017,12ASY0013,12BSY0018,12DSY0019,12FSY0005, 12HSY0024,12HSY0039,12LSY0020,13BSY0015,13FSY0015,13FSY0021,13KSY0011,13MSY0005, 14BSY0010,14CSY0008,14FSY0010,15ASY0014,15CSY0007,15FSY0062,15JSY0005,15LSY0069, 16ASY0004,16ESY0060,448956B,488987A,495483A

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.