The Recall Desk
LowFDA (Devices)·Z-0553-2015·Announced 2014-12-17

Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues

Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is driven by regulatory compliance and documentation issues regarding pre-amendment status, with no reported injuries, illnesses, or physical defects cited in the source text.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 22 springloaded titanium fixation screws from the market. These devices are used in traction skull tongs to immobilize patients with cervical spine injuries, such as fractures or dislocations. The screws are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.

The reason for this withdrawal is that Instrumed did not market these specific devices prior to September 26, 1976. Consequently, the devices do not meet all FDA requirements to be marketed as "Pre-Amendment" devices. The affected units are distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

Healthcare facilities and distributors should stop using these specific devices and contact Instrumed International for further instructions. Consumers should not use these medical devices if they have them in their possession.

The recalled product

Product
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 name
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
22

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 28 recalled by Instrumed International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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