Recall Z-0082-2013 ยท LXH Orthopedic Manual Surgical Instrument
Aesculap, Inc.
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
| Date | Oct 18, 2012 (initiated May 9, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 2 |
| Distribution | Within the US, product was distributed to PA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.