Ascension Orthopedics, Inc: Medical Device Recall in 2019 - (Recall #: Z-0794-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

Product Classification:

Class III

Date Initiated: November 16, 2018

Date Posted: February 13, 2019

Recall Number: Z-0794-2019

Event ID: 81782

Reason for Recall:

The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

Status: Terminated

Product Quantity:

Code Information:

170691

Distribution Pattern:

Distributed to accounts in MO. Foreign distribution to Korea and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated