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Terminated

Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

FDA Recall Z-0082-2013 · Posted 2012-10-18

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2012-05-09
Date Terminated2014-01-15
Product Quantity2

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Within the US, product was distributed to PA and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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