Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch
Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.
- Product
- 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS…
- Category
- Medical Device
- Distribution
- Distributed nationwide