Medshape, INC.: Medical Device Recall in 2025 - (Recall #: Z-2513-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Medshape Universal Joints, REF: DNE-9000-UJ

Product Classification:

Class II

Date Initiated: June 2, 2025

Date Posted: September 10, 2025

Recall Number: Z-2513-2025

Event ID: 97064

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.

Status: Ongoing

Product Quantity: 849

Code Information:

UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated