Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0553-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 8, 2014

Date Posted: December 17, 2014

Recall Number: Z-0553-2015

Event ID: 69471

Reason for Recall:

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Status: Terminated

Product Quantity: 22 titanium fixation screws, springloaded

Code Information:

1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313. 2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments Item Number: 74-0184T; Lot Numbers: 020512, 100512. 3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical Item Number: SS2193AT; Lot Number: 020512. 4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion Item Number: VM85-12955; Lot Number: 050314, 110211, 110313.

Distribution Pattern:

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated