Reported Feb 21, 2018 · Terminated
Norian Drillable Inject
Synthes USA
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 · 1230 Wilson Dr · West Chester, PA · 19380-4231
Is this the product you have?
- Norian Drillable Inject
- Lot codes and dates
- Product Number07.704.010S
- Lot NumberDSE0733
- Amount recalled
- 5 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.
This product could cause temporary or reversible health problems — stop using it.
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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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