Reported Dec 17, 2014 · Terminated
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize 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?
- Traction tong replacement screws, non-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 CareFusion, Boss Instruments, and Stealth Surgical brand names.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published NL9514-T— 638-05429Lot Number: 100512. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed ; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments 74-0185T— 638-05429Lot Numbers: 020512, 100512, 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed ; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical SS2193BT— 638-05429Lot Numbers: 070312. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion VM85-12965— — Lot Numbers: 100512, 110211. - Amount recalled
- 17 traction tong replacement screws, non-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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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