Recall record at a glance
| Official record | Z-1720-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Small Bone Innovations, Inc. |
| Report date | Jun 11, 2014 |
| Recall initiation date | Apr 7, 2014 |
| Quantity | 44 |
| Location | Morrisville, PA, United States |
Official 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.
Why the product was recalled
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.
Distribution information
US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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