FDA Medical Device Recalls (openFDA)
Ascension Orthopedics, Inc: Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Recall number
- Z-0794-2019
- Recalling firm
- Ascension Orthopedics, Inc
- Product
- Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Status
- Terminated
- Initiated
- 2018-11-16
- Posted
- not on file
- Terminated
- 2019-11-22
- Reason
- The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
- 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: custsvcnj@integralife.com Outside USA: 1- 609-936-5400; email: INTERNATIONALCS@integralife.com
- Quantity
- not on file
- Distribution
- Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
- Lot, serial or model codes
- 170691
- 510(k) numbers
- ["K062861"]
- PMA numbers
- not on file
- Product code
- HSD
- Firm FEI
- 3002788818
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28