Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors
Synthes (USA) Products LLC is recalling 4.5 mm Cannulated 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 explicitly states the issue is a labeling mismatch without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws (Product code HWC, Device Listing Numbers D029092 and D120718). The recall involves 19,497,844 units that were distributed nationwide in the United 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 device is 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 should check their inventory for affected units. The source text does not specify further consumer actions or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, 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 D
- 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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