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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling mismatch without reporting any illnesses, injuries, or deaths. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws (Product code HWC, Device Listing Numbers D137404 and D137402). The recall involves 19,497,844 units that were distributed nationwide across the United States, including the District of Columbia and various states.
The reason for the recall is that the product labeling does not match the cleared indications for use in the United States and Canada. The devices are intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures and slipped capital femoral epiphyses.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes (USA) Products LLC for further instructions regarding the return or replacement of the affected units.
The recalled product
- 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 i
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 19,497,844
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Many affected part numbers
Distribution
Part of a larger recall action
This product is one of 7 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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