Reported Mar 27, 2013 · Terminated
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 -…
Extremity Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Extremity Medical LLC · 300 Interpace Pkwy Ste 410A · Parsippany, NJ · 07054-1148
Is this the product you have?
- 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.
- Lot codes and dates
Catalog Number 101-00006Lot Number 00921538
- Amount recalled
- 238 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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