Reported Dec 17, 2014 · Terminated
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a…
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 perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Product as published — Cushing Perforating, Drill, 3/8", 10 mm 600-00509Instrumed — Trade Name: Boss Industries — Boss Industries Product Name: Cushing Perforating, Drill, 3/8", 10 mm 74-0100Boss Industries — Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm 600-00514Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm 57-6034Symmetry Surgical — Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm 600-00514Instrumed — Trade Name: Medfix International — Medfix International Product Name: Cushing Perforating, Drill, 1/2", 13 mm MF223-1577Medfix International — Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm 600-00514Instrumed — Trade Name: Stealth Surgical — Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm SS2122Stealth Surgical - Amount recalled
- 9 perforating drills
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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