Synthes Recalls Norian Drillable Inject Due to Labeling Error
Synthes (USA) Products LLC is recalling Norian Drillable Inject 10 CC-Sterile units because the internal rotary 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, but the hazard is limited to a labeling error where the actual product contents are correct, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Synthes (USA) Products LLC is initiating a voluntary recall of 2,098 units of Norian Drillable Inject 10 CC-Sterile (catalog # 07.704.010S). The product is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
The recall is due to a labeling discrepancy where the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume or size. However, the source text confirms that the rotary pouch contains the correct powder volume and size according to the outer label.
The affected products were distributed nationwide to all 50 states and Washington, D.C., as well as internationally to Canada. The recall covers specific catalog IDs (07.704.003S, 07.704.005S, and 07.704.010S) and a list of 33 specific lot numbers. Healthcare providers and patients should check their inventory or records for these specific lot and catalog numbers.
The recalled product
- Product
- Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 2,098
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
- DSD2506
- DSD3236
- DSC1747
- DSC1748
- DSC2468
- DSC3590
- DSC3874
- DSC6847
- DSC7713
- DSC8449
- DSC9067
- DSC9142
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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