Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
FDA device recall Z-0082-2013 · posted 2012-10-18 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 2
- Distribution
- Within the US, product was distributed to PA and TN.
- Date initiated
- 2012-05-09
- Date posted
- 2012-10-18
- Date terminated
- 2014-01-15
- Location
- Center Valley, PA
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