Reported Mar 9, 2016 · Terminated
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined…
Stryker Instruments Div. of Stryker Corporation
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 Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
- Lot codes and dates
- 50000
- Lot numbers61305001, 61310001, 61312001, 61404006 Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number
- Amount recalled
- 5,800 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
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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