FDA Device recall Z-1701-2015
Tibial Alignment Guide
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Tibial Alignment Guide by Zimmer Cas, citing zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1701-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-19 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Cas |
| Distribution | US |
Product
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Reason
Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
Identifiers
| code_info | Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1701-2015%22
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