Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) |
|---|---|
| Recall Number | Z-0082-2013 |
| Classification | Class II |
| Code Info | NQ083R |
| Product Distributed Qty | 2 |
| 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. |
Event Detail
| Event Id | 63223 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Aesculap, Inc. |
| City | Center Valley |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-09 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Within the US, product was distributed to PA and TN. |
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