Medshape, INC. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Medshape Universal Joints, REF: DNE-9000-UJClass IIJun 2, 2025Bone external fixation system may have the pin that can beco	Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the u	Class IIDevices	Jun 2, 2025
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, SterileClass IINov 17, 2021The firm identified a nonconformance in Lot 04882 involving	The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length t	Class IIDevices	Nov 17, 2021