FDA Medical Device Recalls (openFDA)
Extremity Medical LLC: 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.
- Recall number
- Z-0952-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-01-10
- Posted
- 2013-03-15
- Terminated
- 2013-07-18
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Catalog Number 101-00006; Lot Number 00921538.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXI
- Firm FEI
- 3007289093
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28