FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
- Recall number
- Z-0082-2013
- Recalling firm
- Aesculap, Inc.
- Product
- Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
- Status
- Terminated
- Initiated
- 2012-05-09
- Posted
- 2012-10-18
- Terminated
- 2014-01-15
- 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.
- Lot, serial or model codes
- NQ083R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28