FDAFDA · Food and drugs·Recall number Z-0082-2013
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Published October 24, 2012 · Recall initiated: May 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The manufacturer informed the recalling firm of a potential laser marking error in size identification on two Columbus 4-IN-1 Femoral Cutting Guide Instruments. The guides are correctly dimensioned, but the laser markings have been incorrectly etched.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Within the US, product was distributed to PA and TN.
- Lot
- NQ083R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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