Recall Z-2513-2025 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medshape, INC.
Medshape Universal Joints, REF: DNE-9000-UJ
| Date | Sep 3, 2025 (initiated Jun 2, 2025) |
| Status | Open, Classified |
| Reason | Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use. |
| Root cause | Process control |
| Action | On 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to FAsalessupport@enovis.com If you have any questions, contact firm at productsafety@enovis.com |
| Quantity | 849 |
| Distribution | US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151580 | D.N.E. External Fixation System Dne, LLC, Feb 16, 2016 |