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Terminated

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

FDA Recall Z-2500-2020 · Posted None

Recalling FirmXTANT Medical
Recall StatusTerminated
Product CodeHWA
Date Initiated2020-05-12
Date Terminated2021-03-19
Product Quantity4 units

Reason for Recall

The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

Firm 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.

Root Cause

Process design

Distribution Pattern

AZ, TX and WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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