Reported Dec 17, 2014 · Terminated
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and…
Instrumed International, Inc.
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: Instrumed International, Inc. · 626 Cooper Ct · Schaumburg, IL · 60173-4537
Is this the product you have?
- Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published — Cushing Burr, 3/8", 10 mm 600-00529Instrumed — Trade Name: Medfix International — Medfix International Product Name: Cushing Burr, 3/8", 10 mm MF223-1592Medfix International — Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr, 5/8", 16 mm 600-00534Instrumed — Trade Name: Medfix International — Medfix International Product Name: Cushing Burr, 5/8", 16 mm MF223-1597Medfix International — Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr, 3/4", 20 mm 600-00539Instrumed — Trade Name: Stealth Surgical — Stealth Surgical Product Name: Cushing Burr, 3/4", 20 mm SS2133Stealth Surgical — Lot Number: 060311. - Amount recalled
- 4 Cushing burrs
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
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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