Medshape Universal Joints, REF: DNE-9000-UJ
FDA device recall Z-2513-2025 · posted 2025-09-03 · Open, Classified
Recall details
- Recalling firm
- Medshape, INC.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KTT
- Quantity affected
- 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.
- Date initiated
- 2025-06-02
- Date posted
- 2025-09-03
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D.N.E. External Fixation System (K151580) | Dne, LLC | 2016-02-16 |