Integra Cadence Total Ankle System recallZ-1192-2017 · Integra LifeSciences Corp. · initiated Jan 20, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Posterior tibial fractures have been reported.
FDA root cause category: Use error
What the company is doing
The firm intends to update the surgical technique only. No product will be returned. US and non-US consignees were notified by letter delivered by traceable fax or e-mail on 01/20/2017.
Recall details
- Recall number
- Z-1192-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 20, 2017
- Posted by the FDA
- Feb 11, 2017
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 944 units
- Product code
- HSN
- FDA submissions
- K151459
- Distribution
- Nationwide
Product description
Integra Cadence Total Ankle System
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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, QJ0476; 10207202 Cadence Tibial Tray, Size 2, Left Lots: QJ0242, QJ0242-1-G, QJ0242-2-G, QJ0242-G, QJ0478, QJ0478-G, QJ0507-G; 10207203 Cadence Tibial Tray, Size 3, Left Lots: QJ0244, QJ0244G, QJ0253, QJ0480, QJ0480-G, QJ0509-G; 10207204 Cadence Tibial Tray, Size 4, Left Lots: QJ0246, QJ0246G, QJ0255, QJ0482; 10207205 Cadence Tibial Tray, Size 5, Left Lots: QJ0248, QJ0248G, QJ0257, QJ0484; 10207211 Cadence Tibial Tray, Size 1X, Left Lots: QJ0241, QJ0241G, QJ0477, QJ0477-G, QJ0506; 10207212 Cadence Tibial Tray, Size 2X, Left Lots: QJ0243, QJ0243G, QJ0252, QJ0479, QJ0479-G, QJ0508, QJ0508-G; 10207213 Cadence Tibial Tray, Size 3X, Left Lots: QJ0245, QJ0245G, QJ0481, QJ0481-G, QJ0510, QJ0510-G; 10207214 Cadence Tibial Tray, Size 4X, Left Lots: QJ0247, QJ0247-G, QJ0256, QJ0483, QJ0483-G, QJ0511, QJ0511-G
Other devices under the same FDA submission
14 devices cleared under K151459 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cadence Total Ankle System 10207112Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Cadence Total Ankle System 10208103Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Cadence™ 10208102Ascension Orthopedics, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Cadence Total Ankle System 10208101Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Cadence Total Ankle System 10207101Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207102Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207113Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10207211Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10209337Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence Total Ankle System 10209406Smith & Nephew, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence™ 10209208Ascension Orthopedics, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Cadence™ 10207101Ascension Orthopedics, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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