MEDTECH ROSA Spine 1 — Class II medical device recall Z-1755-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-04-19, distributed nationwide. Unapproved change made by the supplier.
| Recall number | Z-1755-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-02-27 |
| Classified | 2017-04-07 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | unapproved product |
| Serial numbers | SP16008 |
Product
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.
Reason for recall
Unapproved change made by the supplier.
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-1755-2017. 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.