Drug recall
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
FDA recall event 74687 · Class II · Zimmer Biomet Spine, Inc
Key facts
| Event ID | 74687 |
|---|---|
| Recall numbers | Z-2397-2016, Z-2398-2016 |
| Recalling firm | Zimmer Biomet Spine, Inc |
| Product type | Devices |
| Products | Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile., Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 30, 2016 |
| Report date | Aug 17, 2016 |
| Termination date | Mar 15, 2017 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 3004485144 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: