Summary
The FDA issued a Class II for Medshape Universal Joints, REF: DNE-9000-UJ by Medshape, INC.. 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 .
Details
Source
Device Recall
External ID
Z-2513-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
Medshape Universal Joints, REF: DNE-9000-UJ
Lot/Code Info: UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Quantity Affected: 849
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-02
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medshape, INC. has 7 FDA actions in our database, including 2 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medshape, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medshape, INC. have FDA actions?
Medshape, INC. has 7 FDA actions in our database, including 2 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2513-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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