Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument — Class II medical device recall Z-0082-2013
Terminated recall by Aesculap, Inc., reported 2012-10-24, distributed in PA, TN. The manufacturer informed the recalling firm of a potential laser marking error in size identification on two
| Recall number | Z-0082-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2012-05-09 |
| Classified | 2012-10-18 |
| Reported by FDA | 2012-10-24 |
| Terminated | 2014-01-15 |
| Distributed | PA, TN |
| Quantity | 2 |
Product
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0082-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.