Grace Medical recalls Stapes Prosthesis model 409-375 with incorrect functional length labeling. This may affect surgical implants. Consumers should contact Grace Medical for details.
Due to incorrect functional length on device labeling.
Grace Medical is recalling a specific stapes prosthesis model (409-375) because the device labeling has an incorrect functional length. This could lead to improper surgical fitting if used without correction.
The labeling error means the device's actual length might not match what's required for proper surgical fitting. This could cause improper placement during hearing restoration procedures.
Surgical patients who received this specific stapes prosthesis model during procedures. Patients using the device for hearing restoration are most at risk.
Check for model/catalog number 409-375 on the device. The UDI code (01)00844505000772(10)122927(17)310301 and lot number 122927 are also associated with this recall.
Reach out to Grace Medical directly for specific instructions on handling the recalled device.
The recall indicates a labeling error, but the device itself is safe if used correctly. Contact Grace Medical for guidance.
Look for model/catalog number 409-375, UDI code (01)00844505000772(10)122927(17)310301, or lot number 122927 on the device.
Contact Grace Medical directly for specific instructions on handling the recalled device.
We’ve drafted a message you can send Grace Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2308-2026 — Grace Medical Grace Medical Hello, I own a Grace Medical that is covered by recall Z-2308-2026 from Grace Medical. 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.
