SBi RingFix Olive Wires Product Usage: These are temporary devices… — Class II medical device recall Z-1720-2014
Terminated recall by Small Bone Innovations, Inc., reported 2014-06-11, distributed nationwide. Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip
| Recall number | Z-1720-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Small Bone Innovations, Inc., Morrisville, PA, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 44 |
| Reason classes | labeling, sterility |
| Lot numbers | V3R0R |
| Model numbers | 451-3004 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1720-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.