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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 Device Recall SBi RingFix Olive Wiressee related information
Date Initiated by FirmApril 07, 2014
Date PostedJune 04, 2014
Recall Status1 Terminated 3 on October 20, 2014
Recall NumberZ-1720-2014
Recall Event ID 68039
510(K)NumberK071394 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductSBi 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 PA 19067-2507
For Additional Information ContactCustomer 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		Packaging process control
ActionSBi 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 Commerce44
DistributionUS Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KTT
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