Z-1916-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- March 30, 2017
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2017 units
Product Description
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
Reason for Recall
The stability data does not support the product labeled with a 10-year shelf life.
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
Code Information
Batch numbers: 07MSY0006,07MSY0011,07MSY0011A,08CSY0037,08CSY0042,08ESY0082,08FSY0037, 08FSY0037B,08FSY0037C,08JSY0008,08LSY0014,09BSY0012,09JSY0010,09JSY0011,09JSY0012, 10CSY0005,10CSY0017,10CSY0018,10KSY0033,11GSY0004,11GSY0024,11JSY0009,11KSY0068, 11MSY0019,12ASY0011,12BSY0013,12DSY0015,12DSY0029,12FSY0006,12FSY0030,12HSY0023, 12HSY0037,12KSY0023,12LSY0019,12MSY0004,12MSY0018,13BSY0007,13BSY0014,13BSY0041, 13FSY0017,13FSY0019,13LSY0009,13LSY0011,13MSY0003,14ASY0001,14BSY0026,14CSY0035, 14GSY0017,14KSY0017,14LSY0012,15BSY0009,15ESY0009,15ESY0038,15FSY0053,15GSY0017, 15JSY0004,16ASY0003,16BSY0013,16ESY0076,431612,431614,433667,4500029102,4500034104, 455856,469005,472439,472439A,477931,483297,483890,491378,491378A,493639,494049,494154