Z-2513-2025Class II

Medshape Universal Joints, REF: DNE-9000-UJ

Name: Z-2513-2025 Medshape Universal Joints, REF: DNE-9000-UJ
Creator: Medshape, INC.
Published: 2025-06-02
License: https://open.fda.gov/license/

Medshape, Inc. / initiated 2025-06-02 / Open, Classified / root cause: manufacturing process

FDA source

Medshape, INC. began a recall of Medshape Universal Joints, REF: DNE-9000-UJ on 2025-06-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2513-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-02
Posted: 2025-09-03
Recalling firm: Medshape, Inc.
Product: Medshape Universal Joints, REF: DNE-9000-UJ
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2513-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2513-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03

Product code KTT

K151580Class IID.N.E. External Fixation SystemDne, LLC / cleared 2016-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)