Extremity Medical LLC: Medical Device Recall in 2013 - (Recall #: Z-0952-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.

Product Classification:

Class II

Date Initiated: January 10, 2013

Date Posted: March 27, 2013

Recall Number: Z-0952-2013

Event ID: 64330

Reason for Recall:

The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.

Status: Terminated

Product Quantity: 238 units

Code Information:

Catalog Number 101-00006; Lot Number 00921538.

Distribution Pattern:

Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated