Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch. |
|---|---|
| Recall Number | Z-2151-2012 |
| Classification | Class II |
| Code Info | Lot 318455 |
| Product Distributed Qty | 2 |
| Reason For Recall | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. |
Event Detail
| Event Id | 62665 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Linvatec Corp. dba ConMed Linvatec |
| City | Largo |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- US and Korea. |
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