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U.S. Department of Health and Human Services

Enforcement Report - Week of August 15, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot 318455 Class II 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. 2 Z-2151-2012
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