Reported Dec 17, 2014 · Terminated
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with 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?
- Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Product as published NL9513-T— 638-05409Lot Number: 012412. 2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion NL9515-T— 638-05409Lot Number: 012412. 3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed ; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical 6-1944LN— 638-05409Lot Number: 012412. 4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed ; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments 74-0181T— 638-05409Lot Number: 012412. 5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed ; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical SS2195T— 638-05409Lot Number: 012412. 6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion VM85-12925— — Lot Number: 012412. - Amount recalled
- 49 lock nuts for titanium traction tongs
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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