FDA Device recall Z-2397-2016
Zyston¿ Transform Instrument Case
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Zyston¿ Transform Instrument Case by Zimmer Biomet Spine, citing 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 impl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2397-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-30 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet Spine |
| Distribution | US |
Product
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Reason
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.
Identifiers
| code_info | Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2397-2016%22
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