Recall Z-2398-2016 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Zimmer Biomet Spine, Inc
Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
| Date | Jun 30, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email not |
| Quantity | 5 |
| Distribution | Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153695 | Biomet Spine Fusion System Biomet Spine, LLC, Jan 21, 2016 |