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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description 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.
Recall Number Z-1720-2014
Classification Class II
Code Info item #451-3004, lot V3R0R.
Product Distributed Qty 44
Reason For Recall 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.

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 Letter
Distribution Pattern US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.