DePuy Synthes SYNMESH 10mm diameter 18mm height titanium mesh for spinal implants has incorrect labeling as a general medical device instead of specially controlled medical device. This may affect regulatory compliance but does not pose immediate safety risks.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
DePuy Synthes is recalling SYNMESH 10mm diameter 18mm height titanium mesh implants for spinal surgery. The recall is due to incorrect labeling on the product as a general medical device instead of a specially controlled medical device, which could affect regulatory compliance but does not pose immediate safety risks.
The product is incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could lead to regulatory compliance issues but does not cause physical harm or injury during normal use.
Spinal surgery patients who received the SYNMESH 10mm diameter 18mm height titanium mesh implants. Surgeons and hospitals using these implants for cervical, thoracic, or lumbar spine procedures are most at risk.
Check for the product name 'SYNMESH 10MM DIA 18MM HEIGHT (TI)' with product number 495.344. The implants are used for cervical, thoracic, or lumbar spine replacements. Lot numbers H651313, H667046, and M22 are affected.
Look for the product number 495.344 and lot numbers H651313, H667046, or M22 on the implant packaging.
No, the labeling error does not pose immediate safety risks. The product is safe for use but may have regulatory compliance issues.
Check the product label for the product number 495.344 and lot numbers H651313, H667046, or M22. If you have these, contact DePuy Synthes for guidance.
The product is incorrectly labeled as a general medical device instead of a specially controlled medical device, which could affect regulatory compliance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0403-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0403-2021 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.
