Atlanta, GA, United States
Medshape, INC. recalls
2 recalls recorded since 2018, most recently on 2 June 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 June 2025
- 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 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2513-2025
- Medshape Universal Joints, REF: DNE-9000-UJ
Ongoing Class II Medical devices
- Recall started
- 17 November 2021
- Reason
- The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
- Distribution
- Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0453-2022
- DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.