INCIPIO DEVICES: Medical Device Recall in 2024 - (Recall #: Z-0549-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

Product Classification:

Class II

Date Initiated: October 30, 2024

Date Posted: December 4, 2024

Recall Number: Z-0549-2025

Event ID: 95653

Reason for Recall:

Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.

Status: Ongoing

Product Quantity: 100 units

Code Information:

Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.

Distribution Pattern:

US Nationwide distribution in the state of TN.

Voluntary or Mandated:

Voluntary: Firm initiated