Paragon 28 recalls a specific foot implant model due to elevated oxygen levels potentially reducing material strength. Affected units include Lot AOCIA6123.
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28 is recalling a custom foot implant (Model 6123N R) because it may have elevated oxygen levels that could weaken the material. This could pose a risk if the implant fails under stress.
The implant may have elevated oxygen levels beyond safe limits, which can reduce its material strength. This could lead to failure if the implant is subjected to stress.
People who own or use the specific custom foot implant model with Lot Number AOCIA6123 are affected. Those with this implant are most at risk.
Check for the model number 6123N R and lot number AOCIA6123 on the implant. This specific custom foot implant was sold under the Paragon 28 brand.
Look for the model number 6123N R and lot number AOCIA6123 on the implant.
The recall states elevated oxygen levels may reduce material strength, but no specific injury risk is mentioned. The hazard is not severe enough to require immediate action.
Check for the model number 6123N R and lot number AOCIA6123 on the implant.
The recall does not specify a remedy, so no action is required beyond checking the implant details.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-2972-2026 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-2972-2026 from Paragon 28. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
