CLASS III Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
Ascension Modular Radial Head (MRH) Radial Head Implant recalled
Ascension Orthopedics is recalling Ascension Modular Radial Head (MRH) Radial Head Implant, distributed in Missouri. The recall was initiated on 16 Nov 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0794-2019
- FDA event ID
- 81782
- Recalling firm
- Ascension Orthopedics, Austin, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Nov 2018
- FDA classified
- 1 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 16 Nov 2018 | Recall initiated by company | |
| 1 Feb 2019 | Classified by FDA | +77 days |
| 13 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Where it was distributed
Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Questions about this recall
Why was it recalled?
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Which lots are affected?
170691
Where was it sold?
Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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