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 #14493314D252and 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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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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