Recall Z-2146-2023 ยท HXK Holder, Needle; Orthopedic
Aesculap Implant Systems LLC
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
| Date | Jul 14, 2023 (initiated May 18, 2023) |
| Status | Open, Classified |
| Reason | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. |
| Root cause | Labeling Change Control |
| Action | Aesculap Inc, a B. Braun company issued Urgent Medical Device Recall Notification Letter dated 5/18/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Determine your current inventory of the affected product within your facility. (See for instructions in identifying impacted devices.) 3. Cease use and quarantine product subject to recall. 4. Utilizing the attached "P |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the states of DC, MO, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.