RecallRadar

FDA Device recall Z-1192-2017

Integra Cadence Total Ankle System

On 2017-02-22 the FDA classified a Class II recall of Integra Cadence Total Ankle System by Integra Lifesciences, citing posterior tibial fractures have been reported.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1192-2017
ClassificationClass II
Statusterminated
Initiated2017-01-20
Published2017-02-22
Last updated2026-09-13 11:54 UTC
CompanyIntegra Lifesciences
DistributionUS

Product

Integra Cadence Total Ankle System

Reason

Posterior tibial fractures have been reported.

Identifiers

code_info
Model Number, Item Description, and Lot Number: 10207101, Cadence Tibial Tray, Size 1, Right Lots: QJ0231, QJ0231-G, QJ…Model Number, Item Description, and Lot Number: 10207101, Cadence Tibial Tray, Size 1, Right Lots: QJ0231, QJ0231-G, QJ0467, QJ0467-G; 10207102 Cadence Tibial Tray, Size 2, Right Lots: QJ0227, QJ0227-G, QJ0233, QJ0469, QJ0500, QJ0500-G; 10207103 Cadence Tibial Tray, Size 3, Right Lots: QJ0235, QJ0235-1, QJ0235-1-G, QJ0471, QJ0502-G; 10207104 Cadence Tibial Tray, Size 4, Right Lots: QJ0237, QJ02371, QJ0237-1G, QJ0237-G, QJ0473, QJ0504-G; 10207105 Cadence Tibial Tray, Size 5, Right Lots: QJ0239, QJ0239-1-G, QJ0239G, QJ0475; 10207111 Cadence Tibial Tray, Size 1X, Right Lots: QJ0232, QJ0232-G, QJ0468, QJ0499-G; 10207112 Cadence Tibial Tray, Size 2X, Right Lots: QJ0228, QJ0228-G, QJ0234, QJ0234-G, QJ0470, QJ0501-G; 10207113 Cadence Tibial Tray, Size 3X, Right Lots: QJ0236, QJ0236-1, QJ0236-1-1G, QJ0236-1G, QJ0472, QJ0503, QJ0503-G; 10207114 Cadence Tibial Tray, Size 4X, Right Lots: QJ0238, QJ0238G, QJ0474, QJ0505-G; 10207201 Cadence Tibial Tray, Size 1, Left Lots: QJ0240, QJ0240G, QJ0249

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1192-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.