Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
- Company
- Aesculap Inc
- Recall Initiated
- May 9, 2012
- Posted
- October 18, 2012
- Terminated
- January 15, 2014
- Recall Number
- Z-0082-2013
- Quantity
- 2
- Firm Location
- Center Valley, PA
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.
Distribution
Within the US, product was distributed to PA and TN.
Lot / Code Info
NQ083R
Root Cause
Process change control
Action Taken
Both consignees were notified verbally on May 15, 2012 and asked to inspect their inventory for the recalled items, remove the mislabeled instruments and return them to the recalling firm. Both mislabeled instruments were returned to the firm. Customer questions were directed to (610) 984-9074.
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