Recall Z-1720-2014— Small Bone Innovations, Inc.
Class II · Terminated
Class II FDA medical device recall by Small Bone Innovations, Inc., initiated 2014-04-07, terminated 2014-10-20. It names one FDA 510(k) clearance: K071394. 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.. Reason: 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..
- Recalling firm
- Small Bone Innovations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-07
- Terminated
- 2014-10-20
- Firm location
- Morrisville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.