Synthes recalls SYNMESH 15mm diameter 88mm height titanium vertebral implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect safety compliance.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling a specific type of titanium vertebral implant (SYNMESH 15MM DIA 88MM HEIGHT) because it's incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could lead to improper regulatory oversight and potential safety issues for patients.
The product is labeled incorrectly as a general medical device when it should be classified as a specially controlled medical device. This mislabeling could result in improper regulatory oversight and potential safety risks during medical procedures.
Patients who received the SYNMESH 15MM DIA 88MM HEIGHT titanium implants for spinal fusion procedures are likely affected. Surgeons and medical facilities using these implants for cervical, thoracic, or lumbar spine procedures are at risk.
Check for the product name 'SYNMESH 15MM DIA 88MM HEIGHT (TI)' with product number 495.366. Look for lot numbers 16L1245, 16L7630, 42P1145, 42P4281, or M22 on the packaging.
Verify the product label for the correct classification as a specially controlled medical device, not a general medical device.
The product is incorrectly labeled as a general medical device instead of a specially controlled medical device, which could lead to improper regulatory oversight.
Product number 495.366.
Lot numbers 16L1245, 16L7630, 42P1145, 42P4281, and M22.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0405-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0405-2021 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.
