Z-0952-2013Class II

Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006...

Name: Z-0952-2013 Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006...
Creator: Extremity Medical LLC
Published: 2013-01-10
License: https://open.fda.gov/license/

Extremity Medical, LLC / initiated 2013-01-10 / Terminated

FDA source

Extremity Medical LLC began a recall of Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical... on 2013-01-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0952-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-10
Posted: 2013-03-15
Terminated: 2013-07-18
Recalling firm: Extremity Medical, LLC
Product: 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 code: HXI Passer, Wire, Orthopedic
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.
FDA root cause: Component change control
Action: Extremity Medical sent an "URGENT: FIELD SAFETY NOTICE" dated January 10, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return. Contact Customer Service at 1 (973) 588-8980 for questions regarding this notice. On April 10, 2013, Extremity sent notifications to their customers at the surgeon level. They were asked to complete the attached product field action response form.
Quantity in commerce: 238 units
Distribution: 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.
Product codes and lots: Catalog Number 101-00006; Lot Number 00921538.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0952-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0952-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

Product code HXI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)