The Recall Desk
HighFDA (Devices)·Z-2500-2020·Announced 2020-07-15

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.

What this means for you

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
Category
Medical Device — Surgical Instrument
Hazard
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

Distributed in 3 states:

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