Paragon 28 recalls a specific foot implant model due to potential oxygen level issues that could reduce material strength. Affected units include the 6123S R model with lot number 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 specific foot implant model (6123S R) because it may have elevated oxygen levels that could weaken the material. This recall affects people who received this implant for foot surgery.
The implant may have elevated oxygen levels beyond safe limits, which can reduce the material's ability to stretch or bend under stress. This could potentially lead to failure in the implant's function over time.
People who received the Paragon 28 Custom Made Device Implant 6123 Navicular Cage Small Right Rev A (model 6123S R) for foot surgery are affected. Those with this specific implant are most at risk.
Check for the model number 6123S R on the implant, and look for the lot number AOCIA6123. This specific implant was sold for foot surgery procedures.
Identify the model number (6123S R) and lot number (AOCIA6123) on your implant.
The recall states there is a potential risk of reduced material strength due to elevated oxygen levels, but no specific injuries have been reported.
Check the model number and lot number on your implant. If it matches 6123S R and AOCIA6123, contact Paragon 28 for further instructions.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-2971-2026 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-2971-2026 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.
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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.
