Tibial Alignment Guide — Class II medical device recall Z-1701-2015
Terminated recall by Zimmer CAS, reported 2015-06-10, distributed nationwide. Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to be
| Recall number | Z-1701-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer CAS, Montreal, N/A, Canada |
| Recall initiated | 2015-04-19 |
| Classified | 2015-06-02 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 78 devices |
| Reason classes | device malfunction |
| Lot numbers | 110623, 120265, 120659, 120659-1, 120793, 120794, 130134, 130135 |
| Model numbers | 20-8011-013-00 |
Product
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1701-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.