Reported Dec 17, 2014 · Terminated
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with…
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?
- Titanium fixation screws, springloaded 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 Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published 6-1944TS— 638-05421Lot Numbers: 100512, 110313. 2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed ; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments 74-0184T— 638-05421Lot Numbers: 020512, 100512. 3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed ; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical SS2193AT— 638-05421Lot Number: 020512. 4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion VM85-12955— — Lot Number: 050314, 110211, 110313. - Amount recalled
- 22 titanium fixation screws, springloaded
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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