Z-1720-2014Class II

SBi RingFix Olive Wires

Name: Z-1720-2014 SBi RingFix Olive Wires
Creator: Small Bone Innovations, Inc.
Published: 2014-04-07
License: https://open.fda.gov/license/

Small Bone Innovations, Inc. / initiated 2014-04-07 / Terminated / root cause: packaging

FDA source

Small Bone Innovations, Inc. began a recall of SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of... on 2014-04-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1720-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-07
Posted: 2014-06-04
Terminated: 2014-10-20
Recalling firm: Small Bone Innovations, Inc.
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: item #451-3004, lot V3R0R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1720-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1720-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code KTT

K071394Class IIModification To:sbi RingfixSmall Bone Innovations, Inc. / cleared 2007-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)