XTANT Medical Recalls Irix-C Forceps Inserter Due to Fracture Risk
XTANT Medical is recalling four Irix-C Forceps Inserters because the strike plate may fracture off due to unsatisfactory welds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the High severity category.
Plain-English summary
XTANT Medical is recalling four units of the Irix-C Forceps Inserter (Product Code/UDI: T066-0059/ M697T06600591). The recall is limited to devices with lot number XS1920458A. These devices were distributed in Arizona, Texas, and West Virginia.
The recall was initiated because the strike plate fractured off from the forceps inserter devices with minimal impaction or force. This failure is attributed to unsatisfactory welds. The agency has classified this recall as Class II.
Healthcare facilities and consumers who possess these specific devices should stop using them immediately. Users should contact XTANT Medical for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
- Manufacturer
- XTANT Medical
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT: XS1920458A
Distribution
Related recalls
Same manufacturer · XTANT Medical
See all →- HighSpinal Fusion Implant Insert Recalled for Assembly Defect
FDA (Devices) · 2022-02-09
- LowXTANT Medical Recalls Cervical Implants Due to Incorrect Titanium Grade Labeling
FDA (Devices) · 2020-11-18
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- SevereAcutus Medical Recalls Rhythm Xience Flextra Steerable Introducers Due to Foreign Material
FDA (Devices) · 2020-04-29
- HighSpinal Fusion Implant Insert Recalled for Assembly Defect
FDA (Devices) · 2022-02-09
- HighImplantable defibrillator recalled for manufacturing defect causing device failure risk
FDA (Devices) · 2024-07-03
- SevereWright Medical Recalls Crosscheck Plating System Due to Spec Deviations
FDA (Devices) · 2015-04-29
- SevereAcutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material
FDA (Devices) · 2020-04-29
- HighMAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk
FDA (Devices) · 2018-08-08