Smith & Nephew, Inc. Recall 89443
Description: 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
Smith & Nephew, Inc. Recall 89443 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0635-2022 |
| Event ID | 89443 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada. |
| Quantity | 271 units |
| Recall Reason | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process |
| Device Classification | 20220216 |
| Device Code Info | Lot Numbers: 50971615, 50971617 & 50967788 |
| Center Classification Date | 20220210 |
| Recall Initiation Date | 20211214 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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