Medshape Universal Joints (Medshape) – Frame Instability Risk (2025)
Dislodged pin in bone external fixation system can cause frame instability during medical procedures.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Brand
Medshape, INC.
Lot Codes / Batch Numbers
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Products Sold
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Medshape, INC. is recalling Medshape Universal Joints, REF: DNE-9000-UJ due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026