RegWardenFDA facility compliance records
Recall

Class II — Aesculap, Inc.

Recalling firmAESCULAP, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe 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.
ProductColumbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
Quantity2
DistributionWithin the US, product was distributed to PA and TN.
Initiated2012-05-09
Classified2012-10-18
Terminated2014-01-15
Recall numberZ-0082-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Aesculap, Inc. (Z-0082-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63223/

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