Reported Jun 15, 2016 · Terminated
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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.
- Lot codes and dates
Catalog ID 07.704.003S07.704.005S and 07.704.010S
- Lot Numbers
DSC1679DSC3869DSC7712DSC8448DSC9141DSD0256DSD2012DSD2506DSD3236DSC1747DSC1748DSC2468DSC3590DSC3874DSC6847DSC7713DSC8449DSC9067DSC9142DSD0257DSD0919DSD2013DSD2380DSD3237. DSC1676DSC2469DSC3591DSC3879DSC8441DSC9143DSD0055DSD0466DSD1956DSD2381
- Amount recalled
- 2098 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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