Reported Feb 22, 2017 · Terminated
Integra Cadence Total Ankle System
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra Cadence Total Ankle System
- Lot codes and dates
- Model Number, Item Description
- and Lot Number
10207101Cadence Tibial TraySize 1
- Right Lots
QJ0231QJ0231-GQJ0467QJ0467-G10207102 Cadence Tibial TraySize 2
- Right Lots
QJ0227QJ0227-GQJ0233QJ0469QJ0500QJ0500-G10207103 Cadence Tibial TraySize 3
- Right Lots
QJ0235QJ0235-1QJ0235-1-GQJ0471QJ0502-G10207104 Cadence Tibial TraySize 4
- Right Lots
QJ0237QJ02371QJ0237-1GQJ0237-GQJ0473QJ0504-G10207105 Cadence Tibial TraySize 5
- Right Lots
QJ0239QJ0239-1-GQJ0239GQJ047510207111 Cadence Tibial TraySize 1X
- Right Lots
QJ0232QJ0232-GQJ0468QJ0499-G10207112 Cadence Tibial TraySize 2X
- Right Lots
QJ0228QJ0228-GQJ0234QJ0234-GQJ0470QJ0501-G10207113 Cadence Tibial TraySize 3X
- Right Lots
QJ0236QJ0236-1QJ0236-1-1GQJ0236-1GQJ0472QJ0503QJ0503-G10207114 Cadence Tibial TraySize 4X
- Right Lots
QJ0238QJ0238GQJ0474QJ0505-G10207201 Cadence Tibial TraySize 1
- Left Lots
QJ0240QJ0240GQJ0249QJ047610207202 Cadence Tibial TraySize 2
- Left Lots
QJ0242QJ0242-1-GQJ0242-2-GQJ0242-GQJ0478QJ0478-GQJ0507-G10207203 Cadence Tibial TraySize 3
- Left Lots
QJ0244QJ0244GQJ0253QJ0480QJ0480-GQJ0509-G10207204 Cadence Tibial TraySize 4
- Left Lots
QJ0246QJ0246GQJ0255QJ048210207205 Cadence Tibial TraySize 5
- Left Lots
QJ0248QJ0248GQJ0257QJ048410207211 Cadence Tibial TraySize 1X
- Left Lots
QJ0241QJ0241GQJ0477QJ0477-GQJ050610207212 Cadence Tibial TraySize 2X
- Left Lots
QJ0243QJ0243GQJ0252QJ0479QJ0479-GQJ0508QJ0508-G10207213 Cadence Tibial TraySize 3X
- Left Lots
QJ0245QJ0245GQJ0481QJ0481-GQJ0510QJ0510-G10207214 Cadence Tibial TraySize 4X
- Left Lots
QJ0247QJ0247-GQJ0256QJ0483QJ0483-GQJ0511QJ0511-G
- Amount recalled
- 944 units
Where it was sold
- Nationwide
Why it was recalled
Posterior tibial fractures have been reported.
This product could cause temporary or reversible health problems — stop using it.
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