Reported Mar 2, 2016 · Terminated

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used…

Stryker Spine

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: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611

Is this the product you have?

  • Stryker Aero-AL Impaction handle Catalog Number 48921007
  • Stryker Spine Manufactured byStryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space
Lot codes and dates
    • Lot #144933
    • 14D252
    • and 14D253
Amount recalled
31 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

Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 1, 2016 · Data as of Sep 19, 6:17 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.