Device product
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Z-1917-2017
Product summary
- Event
- Event 76943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3748 units
- Official record key
device-enforcement:Z-1917-2017
Official wording
Reason: The stability data does not support the product labeled with a 10-year shelf life.
Code information: Batch numbers: 431612,452406,455856,463451,472439,472579,483890,485498,494049,495483,4357136940, 4500029102,4500029865,4500032273,4500032667,4500064768,07LSY0010,08BSY0013, 08BSY0015,08FSY0032,08FSY0033,08FSY0033A,08JSY0013,08LSY0009,09BSY0015, 09FSY0007,09HSY0004,09HSY0008,09JSY0004,09JSY0004A,10CSY0009,10CSY0009A, 10CSY0019,10CSY0020,10ESY0016,10HSY0005,10KSY0008,11ASY0011,11BSY0006, 11DSY0004,11DSY0014,11DSY0049,11ESY0008,11FSY0010,11GSY0007,11HSY0010, 11JSY0004,11JSY0012,11MSY0022,12ASY0014,12BSY0019,12CSY0001,12CSY0007,12DSY0016, 12ESY0001,12FSY0028,12GSY0008,12HSY0026,12HSY0042,12KSY0025,12MSY0027,13BSY0008, 13BSY0033,13BSY0042,13DSY0008,13FSY0013,13FSY0024,13JSY0024,13KSY0013,13KSY0014, 13KSY0049,13MSY0007,13MSY0028,14BSY0009,14CSY0031,14CSY0040,14GSY0021,14HSY0012, 14KSY0031,14LSY0013,14LSY0015,15ASY0010,15ASY0016,15BSY0012,15CSY0020,15DSY0014, 15ESY0021,15FSY0025,15GSY0018,15JSY0007,15KSY0024,15MSY0010,16ASY0005,16BSY0011, 16ESY0081,472579A
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.