Recall Z-0952-2013— Extremity Medical LLC
Class II · Terminated
Class II FDA medical device recall by Extremity Medical LLC, initiated 2013-01-10, terminated 2013-07-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Extremity Medical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-10
- Terminated
- 2013-07-18
- Firm location
- Parsippany, NJ, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.