Synthes recalls radial head replacement implants due to infection and sepsis risks. All models with specific serial numbers are affected.
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Synthes is recalling radial head replacement implants because they have contraindications for infection, sepsis, and osteomyelitis. This means the implants should not be used in patients with these conditions.
The implants have specific contraindications for use in patients with infections, sepsis, or osteomyelitis. Using these implants in such cases could lead to complications or worsening of the condition.
Patients who have undergone or are scheduled for radial head replacement surgery using these implants are affected. Those with active infections, sepsis, or osteomyelitis are at higher risk.
Check for the product names: Radial Head Replacement System Implant. Look for serial numbers listed in the recall notice, which include specific model numbers like 03.405.000S and 09.405.250S.
If you have an infection, sepsis, or osteomyelitis, do not use this implant.
The implants have contraindications for use in patients with infections, sepsis, or osteomyelitis.
All models with serial numbers listed in the recall, including 03.405.000S and 09.405.250S.
The recall does not specify a return or remedy, so no action is needed beyond checking contraindications.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1072-2022 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1072-2022 from Synthes. 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.
