Integra Cadence Total Ankle System
FDA device recall Z-1192-2017 · posted 2017-02-11 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Posterior tibial fractures have been reported.
- Action taken
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- HSN
- Quantity affected
- 944 units
- Distribution
- Nationwide
- Date initiated
- 2017-01-20
- Date posted
- 2017-02-11
- Date terminated
- 2017-03-30
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Integra Total Ankle Replacement System (K151459) | Ascension Orthopedics | 2015-08-31 |