Recall Z-0406-2018
Smith & Nephew, Inc. · initiated October 23, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
Codes / lots: Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.
Reason for recall
The expiration date provided on the label is incorrect.
FDA-determined cause: Process change control
Action taken
The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to FieldActions@smith-nephew.com.
Details
- Recall number
- Z-0406-2018
- Initiated
- October 23, 2017
- Terminated
- August 24, 2018
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 9 units
- Distribution
- Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN