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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Recall Number Z-0276-2014
Classification Class II
Code Info Part Number:. 00-0903-2634 and lot number 009U2
Product Distributed Qty 7 units shipped
Reason For Recall The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.

Event Detail

Event Id 66450
Product Type Devices
Status Ongoing
Recalling Firm OrthoPediatrics Corp
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-26
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
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