Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors
Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 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 and involves a labeling error where the indications for use do not match the cleared indications. No injuries, illnesses, or deaths are reported in the source text, and the hazard is administrative rather than a direct physical defect causing harm.
Plain-English summary
Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws, Product code HWC, Device Listing Number D029094. The recall involves 19,497,844 units distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico.
The recall was initiated because 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, including femoral neck fractures and slipped capital femoral epiphyses.
Healthcare providers and facilities should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions on the recall process.
The recalled product
- Product
- 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, 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 DH
- 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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