Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 13, 2019
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ascension Orthopedics, Inc recalled Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW - a low-severity action.
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW was recalled by Ascension Orthopedics, Inc in February 13, 2019. Reason: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ S…. Check the official notice for the remedy. Verify recall #Z-0794-2019 with the FDA Devices before acting.
The recall
Ascension Orthopedics, Inc issued this low-severity FDA Devices recall-The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ S….
- Low
- severity level
- Class III
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0794-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0794-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on November 16, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Ascension Orthopedics, Inc is listed as the recalling firm, operating out of Austin, TX. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). Distribution data in the federal record shows the product reached: Distributed to accounts in MO. Foreign distribution to Korea and Thailand.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
0 from same agency
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0794-2019 |
| Date reported | February 13, 2019 |
| Date initiated | November 16, 2018 |
| Recalling firm | Ascension Orthopedics, Inc |
| Firm location | Austin, TX |
| Affected scope | Not disclosed |
| Distribution | Distributed to accounts in MO. Foreign distribution to Korea and Thailand. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0794-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW. Recalled by Ascension Orthopedics, Inc.
Why was this product recalled? ▼
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Low. Recall number: Z-0794-2019.
Where was the recalled product distributed? ▼
Distribution: Distributed to accounts in MO. Foreign distribution to Korea and Thailand..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0794-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.