Recall Z-2513-2025
Medshape, INC. · initiated June 2, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Codes / lots: UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
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.
FDA-determined cause: Process control
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
Details
- Recall number
- Z-2513-2025
- Initiated
- June 2, 2025
- Posted by FDA
- September 3, 2025
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 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.
- Recalling firm
- Medshape, INC., Atlanta, GA