DePuy Synthes Recalls Norian Drillable Inject Due to Labeling Error
DePuy Synthes is voluntarily recalling Norian Drillable Inject 3 CC-Sterile because the internal pouch may be labeled with the incorrect powder volume, though the actual contents are correct.
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 actual product contents are correct, fitting the criteria for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
DePuy Synthes is initiating a voluntary recall of unexpired and unopened units of Norian Drillable Inject 3 CC-Sterile. The recall affects specific part and lot numbers distributed nationwide and internationally.
The recall is due to a potential labeling error where the rotary pouch within the device may display the incorrect powder volume or size. The source text confirms that the rotary pouch contains the correct powder volume and size according to the outer label.
The affected product is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. Consumers and healthcare providers should check their inventory for the specific catalog numbers and lot numbers listed in the recall notice.
The recalled product
- Product
- Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 1,246
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 (20)
- Catalog ID 07.704.003S
- 07.704.005S and 07.704.010S Lot Numbers: DSC1679
- DSC3869
- DSC7712
- DSC8448
- DSC9141
- DSD0256
- DSD2012
- DSC1747
- DSC1748
- DSC2468
- DSC3590
- DSC3874
- DSC6847
- DSC7713
- DSC8449
- DSC9067
- DSC9142
- DSD0257
- DSD0919
Distribution
Part of a larger recall action
This product is one of 3 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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