Recall Z-2513-2025— Medshape, INC.

Name: FDA recall Z-2513-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-02

Class II · Ongoing

Class II FDA medical device recall by Medshape, INC., initiated 2025-06-02. It names one FDA 510(k) clearance: K151580. Product: Medshape Universal Joints, REF: DNE-9000-UJ. 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..

Recalling firm: Medshape, INC.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-02
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K151580 — D.N.E. External Fixation SystemDne, LLC·cleared 2016-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medshape Universal Joints, REF: DNE-9000-UJ

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.