FDA Device recall Z-0952-2013
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile by Extremity Medical, citing 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 sc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0952-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-10 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Extremity Medical |
| Distribution | AZ, CA, FL, IL, MD, NC, NH, NY, OH, OK, PA, TN, TX, VA |
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.
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.
Identifiers
| code_info | Catalog Number 101-00006; Lot Number 00921538. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0952-2013%22
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