Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-…
XTANT Medical Holdings, Inc · Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Open FDA's page for this record- Cfres ID
- 212262
- Product res number
- Z-1177-2025
- Event date initiated
- 2025-01-03
- Event date posted
- 2025-02-19
- Recall status
- Open, Classified
- Res event number
- 96179
- Product code
- OVD
- Firm FEI number
- 3005031160
- Recalling firm
- XTANT Medical Holdings, Inc
- Address 1
- 664 Cruiser Ln
- City
- Belgrade
- State
- MT
- Postal code
- 59714-9719
- Additional info contact
- Michele Dolan 937-847-8400
- Reason for recall
- Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
- Root cause description
- Labeling Change Control
- Product quantity
- 14 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
- Product description
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE))
- Code info
Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028
- Action
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).
- K numbers
- K171567
- Harmonized identifiers (openFDA)
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3080
- Device class
- 2
- K number
- K160291, K211769, K251575, K170592, K143228, K173082, K180502, K191834, K253559, K210590, K254202, K192047, K121211, K120101, K140479, K100802, K083475, K221936, K173606, K150643, K161379, K251829, K161129, K202190, K172083, K172941, K130641, K142487, K142271, K223413, K180695, K212980, K120031, K261408, K231486, K130445, K223146, K120557, K181818, K201087 +165 more
- Registration number
- 3007766698, 9610612, 3018094310, 1000432246, 3005739886, 3008868758, 3007303113, 8020776, 1057425, 8043792, 3015876273, 1226544, 2532027, 1724955, 3008262872, 3013194153, 3010047402, 3005180920, 3005706667, 3015212339, 3007993775, 3012491394, 2134285, 3009051471, 3008864603, 3009887475, 3019837678, 3006846753, 3030412764, 3010370554, 3008114965, 3015216945, 3015151147, 3003477135, 3010866843, 3005641619, 3013820501, 3033509898, 2134470, 3008812560 +224 more
- FEI number
- 3007766698, 1000477302, 3018094310, 1000432246, 3000718490, 3008868758, 3005739886, 3007303113, 3015876273, 4224, 3001237338, 3008262872, 3013194153, 3010047402, 3005180920, 3003058119, 3005706667, 3015212339, 3007993775, 1000139987, 3002808269, 1000069183, 3012491394, 1000306303, 3009051471, 3008864603, 3009887475, 3019837678, 3011764740, 3006846753, 3003015552, 3030412764, 3010370554, 3008114965, 3015216945, 3015151147, 3003477135, 3010866843, 3003690049, 3013820501 +224 more