Z-2500-2020Class II

Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

Name: Z-2500-2020 Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Creator: XTANT Medical
Published: 2020-05-12
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2020-05-12 / Terminated / root cause: manufacturing process

FDA source

XTANT Medical began a recall of Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 on 2020-05-12. FDA classified it as Class II and gives the reason as "The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2500-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-12
Posted: 2020-07-04
Terminated: 2021-03-19
Recalling firm: Xtant Medical Holdings, Inc.
Product: Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Product code: HWA Impactor
Reason for recall: The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 4 units
Distribution: AZ, TX and WV.
Product codes and lots: LOT: XS1920458A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2500-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2500-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)