CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report
Columbus-1 Femoral Cutting Guide M3 Instrument (NQ083R) recalled
Aesculap is recalling Columbus-1 Femoral Cutting Guide M3 Instrument (NQ083R), distributed in Pennsylvania, Tennessee. The recall was initiated on 9 May 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0082-2013
- FDA event ID
- 63223
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2012
- FDA classified
- 18 Oct 2012
- Reported
- 24 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 May 2012 | Recall initiated by company | |
| 18 Oct 2012 | Classified by FDA | +162 days |
| 24 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Where it was distributed
Within the US, product was distributed to PA and TN.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
NQ083R
Where was it sold?
Within the US, product was distributed to PA and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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