Device product
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Z-0082-2013
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 63223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0082-2013
Official wording
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.
Code information: NQ083R
Distribution pattern: Within the US, product was distributed to PA and TN.
Derived failure modes
-
Unknown
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.