Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and

FDA device recall Z-1177-2025 · posted 2025-02-19 · Open, Classified

Recall details

Recalling firm

XTANT Medical Holdings, Inc

Reason for recall

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Action taken

An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers on 1/3/25. Specific actions to be taken by the Customer/User: Xtant is communicating this recall to all customers for which the affected device lot was distributed to. Our records indicate that product(s) affected by this recall were shipped to you. We request that you do the following: 1. Immediately examine your inventory and quarantine any affected products subject to this recall. See enclosed illustration for ease in identifying affected devices (see Attachment 2). 2. Please notify your staff of this Medical Device Recall and provide this notification to any customers for which the recalled product was further distributed. 3. 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 Medical Device Recall 664 Cruiser Lane Belgrade, MT 59714 Email: mdolan@xtantmedical.com Fax: 1-406-388-3380 4. Return Affected Product Contact Michele Dolan at mdolan@xtantmedical.com, or 1-406-599-3667, 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. 5. 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: Irix-A Integrated Lumbar Fusion System RA# 25-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 If you have any questions, please contact Rebecca Lennemann, Vice President of QARA, 1-406-924-5878, from 8a.m. to 5 p.m. (Mountain Time).

Root cause

Labeling Change Control

Status

Open, Classified

Product code

OVD

Quantity affected

14 units

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

Date initiated

2025-01-03

Date posted

2025-02-19

Location

Belgrade, MT

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