Use cautionMedical device recall · FDA · Published June 2, 2025
Medshape Universal Joints Recall: Risk of Frame Instability During Surgery
Medshape recalls Universal Joints REF: DNE-9000-UJ due to potential pin dislodgement causing frame instability. Affected units include specific lots; contact for remedy.
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.
Take action
Contact the company
📍Recalling firmMedshape, INC.1575 Northside Dr Nw Ste 440 · Atlanta, GA 30318-4211
“Medshape Universal Joints Recall: Risk of Frame Instability During Surgery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52166-medshape-universal-joints-recall-risk-of-frame-instability-during-surgery. Based on FDA recall #Z-2513-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2513-2025%22&limit=1).
The FDA announced on June 2, 2025, that Medshape, INC. is recalling Medshape Universal Joints due to a hazard where the pin may become dislodged. This defect can cause frame instability and potentially delay surgery or require revision.
According to the FDA, the bone external fixation system may have a 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 used.
Context
GovInfoNow's records show Medshape, INC. has one other recall on record since November 17, 2021, involving a DYNANAIL MINI Endcap with a risk of improper seating during procedures. Other recent recalls of similar products include the Genesis Push-In Suture Anchor Recall (December 17, 2025), the Merit Medical Custom Procedure Kit Recall (December 4, 2025), and the Genesis Screw-In Anchor Recall (December 17, 2025).
How to tell if you have this one
Check for the model REF: DNE-9000-UJ on the product. Affected units include specific production lots listed in the recall notice.
Brand
Medshape
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot numbers listed in the recall: 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 19 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Illinois, Indiana, Iowa, Massachusetts, Montana, Nevada, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2513-2025 (June 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2513-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.