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Open, Classified

Medshape Universal Joints, REF: DNE-9000-UJ

FDA Recall Z-2513-2025 · Posted 2025-09-03

Recalling FirmMedshape, INC.
Recall StatusOpen, Classified
Product CodeKTT
Date Initiated2025-06-02
Product Quantity849

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.

Firm Action

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 [email protected] If you have any questions, contact firm at [email protected]

Root Cause

Process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151580D.N.E. External Fixation SystemDne, LLC · 2016-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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