Ascension Orthopedics recalls a specific radial head implant due to incorrect instructions packaging. This may cause confusion during surgery. Affected units have 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).
Ascension Orthopedics recalled a specific radial head implant (MRH-350-...). The problem is that it came with instructions for a different implant type, which could lead to surgical confusion.
The implant was packaged with instructions for a different product. This could cause confusion during surgery if the wrong instructions are followed. However, the hazard is limited to the packaging error itself.
Orthopedic surgeons and hospitals that purchased the specific implant model. The risk is low as this is a packaging error, not a safety hazard.
Check for the catalog number MRH-350-04-WW on the implant packaging. The product was sold in 2022 and is identified by the serial number 170691.
Look for the catalog number MRH-350-04-WW on the implant packaging to confirm if it's affected.
The implant was packaged with instructions for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant), which could cause surgical confusion.
The recall record does not mention any remedy or fix for this issue.
Check for the catalog number MRH-350-04-WW on the packaging. The product was sold in 2022 and has the serial number 170691.
We’ve drafted a message you can send Ascension Orthopedics to request your refund or repair — edit it as you like.
Subject: Recall Z-0794-2019 — Ascension Orthopedics Ascension Orthopedics Hello, I own a Ascension Orthopedics that is covered by recall Z-0794-2019 from Ascension Orthopedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
