Recall Z-0082-2013— Aesculap, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesculap, Inc., initiated 2012-05-09, terminated 2014-01-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R). Reason: 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-09
- Terminated
- 2014-01-15
- Firm location
- Center Valley, PA, United States
Product description
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.