XTANT Medical Recalls
Showing 1-3 of 3 recalls
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
On 12/30/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Priority Overnight (Direct Signature Required) to its distributes to notify their customer that a specific lot of their interspinous fusion systems were manufactured out of tolerance resulting in the distal end of the crossbar not properly engaging with the inserts. Customer are instructed to: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete the enclosed Acknowledgement Form, even if customers have no remaining devices in their inventory, and return the completed Acknowledgment Form to the attention of Michele Dolan via: Mail: Xtant Medical Axle Interspinous Fusion 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, as applicable, 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: Axle Interspinous Fusion Recall RA# 21-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 5. To Inform all their staff members of this recall and if affected products have been further distributed to contact all customers. For any questions contact the Director of Regulatory Affairs/Quality Assurance at 1-406-388-0480 ext. 1125 from 8 a.m. to 5 p.m. (Mountain Time).
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
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
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
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices. On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers.