Device product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Z-1910-2017
Product summary
- 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
The stability data does not support the product labeled with a 10-year shelf life.