Recall Z-0794-2019— Ascension Orthopedics, Inc

Name: FDA recall Z-0794-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

Class III · Terminated

Class III FDA medical device recall by Ascension Orthopedics, Inc, initiated 2018-11-16, terminated 2019-11-22. It names one FDA 510(k) clearance: K062861. Product: Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW. Reason: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant)..

Recalling firm: Ascension Orthopedics, Inc
Classification: Class III
Status: Terminated
Initiated: 2018-11-16
Terminated: 2019-11-22
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K062861 — ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEMAscension Orthopedics, Inc.·cleared 2006-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.