Reported Dec 17, 2014 · Terminated
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury…
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?
- Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.
- Lot codes and dates
136 of 136 products
Products covered by this recall Model / number Product as published — Gardner-Wells Traction Tongs Complete 630-05401Instrumed — Trade Name: Millenium Surgical — Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete 12-661025Millenium Surgical — Lot Numbers: 040313, 070512. 2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete 630-05401Instrumed — Trade Name: Echo Instruments — Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete 576-804Echo Instruments — Lot Numbers: 050413, 110212. 3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete 630-05401Instrumed — Trade Name: Millenium Surgical — Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete 6-1945Millenium Surgical — Lot Numbers: 030314, 040313, 050413, 110212. 4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete 630-05401Instrumed — Trade Name: Adler Instrument — Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete ADR1945Adler Instrument - Amount recalled
- 190 Gardner-Wells 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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