Recall Z-0429-2021 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
XTANT Medical
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X0
| Date | Sep 30, 2020 |
| Status | Terminated |
| Reason | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| Root cause | Labeling mix-ups |
| Action | On 9/30/2020 and 10/29/2020, a "Urgent: Medical Device Recall" notification was sent to consignees via FedEx Priority Overnight. In addition to notifying the consignee about the labeling issue, the recall notification as consignees to take the following actions: 1. Immediately examine your inventory and quarantine any affected products subject to this recall. See enclosed illustration for ease in identifying affected products (see Attachment 2). 2. Please complete the enclosed Acknowledgement Form (Attachment 1), even if you have no remaining devices in your inventory, and return the comp |
| Quantity | 508 units |
| Distribution | US: FL, TX, CA, OH, AZ, OH OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173832 | InTice-C Porous Ti Cervical Interbody System X-Spine Systems, Inc., May 17, 2018 |