Z-0082-2013Class II

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

Name: Z-0082-2013 Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Creator: Aesculap, Inc.
Published: 2012-05-09
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-05-09 / Terminated / root cause: manufacturing process

FDA source

Aesculap, Inc. began a recall of Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) on 2012-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0082-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Posted: 2012-10-18
Terminated: 2014-01-15
Recalling firm: Aesculap Inc
Product: Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 2
Distribution: Within the US, product was distributed to PA and TN.
Product codes and lots: NQ083R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0082-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-18

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)