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U.S. Department of Health and Human Services

Class 2 Device Recall SBi RingFix Olive Wires

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 Class 2 Recall
SBi RingFix Olive Wires
see related information
Date Posted June 04, 2014
Recall Status1 Open
Recall Number Z-1720-2014
Recall Event ID 68039
Premarket Notification
510(K) Number
K071394 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
Product 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.
Code Information item #451-3004, lot V3R0R.
Recalling Firm/
Manufacturer
Small Bone Innovations, Inc.
1711 S Pennsylvania Ave
Morrisville, Pennsylvania 19067-2507
For Additional Information Contact Customer Support
215-428-1791
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action SBi sent an Urgent Medical Device Recall dated April 7, 2014, to affected customers (sales consultants, distributors, and end users). The letter identified the affected product, problem and actions to be taken. For questions call 215-428-1791 ext 248.
Quantity in Commerce 44
Distribution US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = SMALL BONE INNOVATIONS INC.
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