Reported Dec 17, 2014 · Terminated
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine…
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 wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published — Gardner-Wells Titanium Wrench 1/2" 638-05441Instrumed — Trade Name: CareFusion — CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2" VM85-12015CareFusion — Lot Number: 011112. 2) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2" 638-05441Instrumed — Trade Name: CareFusion — CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2" NL9516-TCareFusion — Lot Number: 011112. - Amount recalled
- 2 Gardner-Wells wrenches
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Instrumed International, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.