Zyston¿ Transform Implant Kit — Class II medical device recall Z-2398-2016
Terminated recall by Zimmer Biomet Spine, Inc, reported 2016-08-17, distributed nationwide. Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zy
| Recall number | Z-2398-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet Spine, Inc, Broomfield, CO, United States |
| Recall initiated | 2016-06-30 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Lot numbers | 2016244391, 2016244394, 2016244395, 2016244396, 2016244397, 2016244424, 2016244426, 2016244427, 2016244428, 2016244430 |
| Model numbers | PCR8200-3101 |
Product
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Reason for recall
Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
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-2398-2016. 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.