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: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

Recommended Action

Per FDA guidance

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 completed Acknowledgment Form to the Attention of Michele Dolan via: Mail: Xtant Medical InTice-C Porous Ti Cervical Interbody System Recall 664 Cruiser Lane Belgrade, MT 59714 Email: mdolan@xtantmedical.com Fax:1-406-388-3380 3. Return Affected Product Contact Michele Dolan at mdolan@xtantmedical.com, or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices which will be provided at no cost to you. 4. Package the affected products to be returned. Xtant will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container at your earliest opportunity to: ATTN: InTice-C Porous Ti Cervical Interbody System Recall RA# 20-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 If you have any questions, please contact Rebecca Lennemann, Director of RAQA, 1-406-388-0480 ext. 1125, from 8 a.m. to 5 p.m. (Mountain Time). For consignees that have already implanted the device: 1. The product does not pose any health risk. The product is correctly manufactured with commercially pure Titanium (CP-Ti), Grade 2, and as such, there is no need for surgical intervention. 2. This notice is being provided only as a notification of the recall and requires completion of the Customer Acknowl

Distribution

As reported by FDA

AZ, CA, FL, OH, TX