Z-0794-2019Class III

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

Name: Z-0794-2019 Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Creator: Ascension Orthopedics, Inc
Published: 2018-11-16
License: https://open.fda.gov/license/

Ascension Orthopedics, Inc. / initiated 2018-11-16 / Terminated / root cause: supplier

FDA source

Ascension Orthopedics, Inc began a recall of Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW on 2018-11-16. FDA classified it as Class III and gives the reason as "The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0794-2019
Classification: Class III
Status: Terminated
Initiated: 2018-11-16
Posted: 2019-02-02
Terminated: 2019-11-22
Recalling firm: Ascension Orthopedics, Inc.
Product: Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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).
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On 11/16/18, the recalling firm sent out an Urgent Voluntary Medical Device Correction letter via email to affected customers to notify them of the product issue. A second, updated letter was sent on 12/13/18. The firm requests that all recipients please examine their inventory to determine if they have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691. Customers: - If you do have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please discard the First Choice DRUJ System Partial Ulnar Head Implant instructions packaged with the product and use the attached correct IFU provided to you along with this communication letter. Distributors: - If you do have any unused MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please return them to Integra. - We also kindly ask you to provide us the final customer list who may have the affected products. Integra will provide them the correct IFU. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 1- 609-936-5400; email: [email protected]
Distribution: Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Product codes and lots: 170691

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0794-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0794-2019	Class III	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-01

Product code HSD

K062861Class IIAscension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc. / cleared 2006-10-31

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)