Recall Z-0635-2022 ยท KQZ Component, Traction, Non-Invasive
Smith & Nephew, Inc.
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
| Date | Dec 14, 2021 |
| Status | Open, Classified |
| Reason | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process |
| Root cause | Nonconforming Material/Component |
| Action | Smith & Nephew issued Urgent Medical Device (R-2021-11) on 12/14/21 to Hospitals via FedX, to Sales rep. and Foreign Distributor via email.. An updated letter issued 1/14/22 to correct a batch number clerical error. Letters state reason for recall, health risk and action to take: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions a |
| Quantity | 271 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.