The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1944-2016·Announced 2016-06-15

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — Orthopedic Bone Graft
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

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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.

See all 3 products in this recall →

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