Reported Dec 17, 2014 · Terminated
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's…
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?
- CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.
- Lot codes and dates
86 of 86 products
Products covered by this recall Model / number Product as published — CVB Distraction Screw, 12 mm, Non-Sterile 650-11438Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile 57-5106Symmetry Surgical — Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile 650-11438Instrumed — Trade Name: Millennium Surgical — Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile 57-5106Millennium Surgical — Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile 650-11438Instrumed — Trade Name: Medfix International — Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile MF232-9052Medfix International — Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile 650-11438Instrumed — Trade Name: CareFusion — CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile VM84-3602CareFusion - Amount recalled
- 790 distractor screws
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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