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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 63090
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 2012-04-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. Lot # 330889 and Catalog: PFT-00M - No Expiration date Class II ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle. 2 units Z-0164-2013