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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68039
Product Type Devices
Status Ongoing
Recalling Firm Small Bone Innovations, Inc.
City Morrisville
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-07
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy. item #451-3004, lot V3R0R. Class II Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside. 44 Z-1720-2014