Device product
Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Z-2398-2016
Product summary
- Event
- Event 74687
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-2398-2016
Official wording
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.
Code information: Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
Distribution pattern: Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
Derived failure modes
-
Unknown
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.