Z-0406-2018 Class II Terminated
FDA device recall Z-0406-2018 was initiated by Smith & Nephew, Inc. on October 23, 2017 and is designated Class II. Reason for recall: The expiration date provided on the label is incorrect. The recall status is terminated (terminated August 24, 2018). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- October 23, 2017
- Termination Date
- August 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Reason for Recall
The expiration date provided on the label is incorrect.
Distribution Pattern
Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
Code Information
Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.