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U.S. Department of Health and Human Services

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.