Reported Dec 17, 2014 · Terminated
Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull…
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?
- Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
- Lot codes and dates
91 of 91 products
Products covered by this recall Model / number Product as published — Michele Trephine, 6 1/4", shaft, 3/16" OD 590-06491Instrumed — Trade Name: Millennium Surgical — Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD 0-48239Millennium Surgical — Lot Numbers: 020212, 120312. 2) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD 590-06491Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD 57-6305Symmetry Surgical — Lot Numbers: 020212, 100111, 100213, 120312. 3) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD 590-06491Instrumed — Trade Name: Medline Industries — Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD MDG1806301Medline Industries — Lot Numbers: 020212, 100111. 4) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD 590-06491Instrumed — Trade Name: CareFusion — CareFusion Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD VM85-1261CareFusion - Amount recalled
- 74 trephines
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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