Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. |
|---|---|
| Recall Number | Z-2362-2012 |
| Classification | Class II |
| Code Info | Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603. |
| Product Distributed Qty | 2 |
| Reason For Recall | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. |
Event Detail
| Event Id | 62140 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Exactech, Inc. |
| City | Gainesville |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-01-24 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide distribution: USA state of: Arkansas only |
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