Date Initiated by Firm |
April 07, 2014 |
Date Posted |
June 04, 2014 |
Recall Status1 |
Terminated 3 on October 20, 2014 |
Recall Number |
Z-1720-2014 |
Recall Event ID |
68039 |
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 PA 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 |
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 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) Database |
510(K)s with Product Code = KTT and Original Applicant = SMALL BONE INNOVATIONS INC.
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