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.

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.

Free recall alerts

Get alerted about new Synthes USA recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 10, 2018 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.