Z-1912-2017 Class II Terminated
FDA device recall Z-1912-2017 was initiated by Smith & Nephew, Inc. on March 30, 2017 and is designated Class II. Reason for recall: The stability data does not support the product labeled with a 10-year shelf life. The recall status is terminated (terminated August 21, 2019). Affected quantity: 1004 units.
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
- 1004 units
Product Description
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, 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: 431604,431612,431614,448956,477931,484324,485498,488987,495483,450002910,4500029102, 4500031658,08CSY0044,08ESY0009,08ESY0010,08ESY0011,08JSY0034,08LSY0010,10CSY0008, 10ESY0014,11KSY0004,11KSY0024,12BSY0006,12BSY0014,12DSY0020,12HSY0009,12HSY0041, 12MSY0026,13BSY0032,13FSY0012,13FSY0023,13HSY0008,14BSY0015,14CSY0039,14GSY0025, 14KSY0003,15DSY0002,15FSY0020,15MSY0006,16BSY0010,477931B