SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small
FDA device recall Z-1720-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Small Bone Innovations, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 44
- Distribution
- US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
- Date initiated
- 2014-04-07
- Date posted
- 2014-06-04
- Date terminated
- 2014-10-20
- Location
- Morrisville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO:SBI RINGFIX (K071394) | Small Bone Innovations, Inc. | 2007-06-29 |