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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Detail

Product Description OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Recall Number Z-2057-2012
Classification Class II
Code Info Lot number: 7736703 and part number: 00-1050-4308
Product Distributed Qty 15 devices
Reason For Recall The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

Event Detail

Event Id 62351
Product Type Devices
Status Ongoing
Recalling Firm OrthoPediatrics Corp
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-14
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.