FDA Medical devices recall ·
Medshape Universal Joints recall
- Recall number
- Z-2513-2025
- Date
- (initiated June 2, 2025)
- Company / brand
- Medshape, INC.
1575 Northside Dr Nw Ste 440, Atlanta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 849
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
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: Arizona California Colorado Florida Iowa Illinois Indiana Massachusetts Montana North Carolina New Jersey Nevada Ohio Pennsylvania South Carolina Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2513-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.