Recall Z-0406-2018 ยท MDM Instrument, Manual, Surgical, General Use
Smith & Nephew, Inc.
Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
| Date | Oct 23, 2017 |
| Status | Terminated |
| Reason | The expiration date provided on the label is incorrect. |
| Root cause | Process change control |
| Action | 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 direct |
| Quantity | 9 units |
| Distribution | Worldwide Distribution -- US, to the states of TN and NJ; and, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.