Reported Dec 17, 2014 · Terminated
Hudson braces 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?
- Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Product as published P-22880— 600-00479Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed ; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments 74-0121— 600-00484Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only; Instrumed ; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical 57-6004— 600-00484Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only; Instrumed ; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical P-22881— 600-00484Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion VM85-1233— 600-00484Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only; Instrumed ; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments 74-0122— — Lot Number: 100211. - Amount recalled
- 8 Hudson braces
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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