Ascension Radial Head Implant Recalled for Incorrect Instructions for Use
Ascension Orthopedics is recalling specific Radial Head Implants because they were packaged with instructions for a different product.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging error involving incorrect documentation, which fits the criteria for a Low severity score.
Plain-English summary
Ascension Orthopedics, Inc. is recalling the Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number MRH-350-04-WW. The recall was initiated because the product was packaged with the Instructions for Use for a different product, specifically the Ascension First Choice DRUJ System Partial Ulnar Head Implant.
The affected units were distributed to accounts in Missouri, as well as to foreign accounts in Korea and Thailand. The source text does not specify the total number of units recalled or the specific dates of distribution.
Healthcare providers and patients should verify the packaging of their implants to ensure they match the correct Instructions for Use. If the incorrect instructions are found, the product should be returned to the manufacturer or the distributor for replacement.
The recalled product
- Product
- Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Manufacturer
- Ascension Orthopedics, Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 170691
Distribution
Distributed in 1 state:
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