Synthes recalls SYNMESH 12MM DIA 88MM HEIGHT implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects patients with spinal implants.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling spinal mesh implants that were 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 using these implants.
The product was incorrectly labeled as a general medical device on its statutory label instead of being classified as a specially controlled medical device. This misclassification could result in improper regulatory oversight and potential safety risks during medical procedures.
Patients who received the SYNMESH 12MM DIA 88MM HEIGHT spinal implants from Synthes are likely affected. Surgeons and medical facilities that used these implants for spinal procedures may also be impacted.
Check for the product name 'SYNMESH 12MM DIA 88MM HEIGHT (TI)' with product number 495.357. The implants are used for cervical, thoracic, and lumbar spine replacements and were sold with lot numbers 15L4249, 50P8888, and M22.
Look for the product name 'SYNMESH 12MM DIA 88MM HEIGHT (TI)' and product number 495.357 on the implant packaging or device.
The product should be classified as a specially controlled medical device, but the label incorrectly states it is a general medical device.
The recall record does not specify a remedy, so there is no action required beyond checking if you have the product.
Lot numbers 15L4249, 50P8888, and M22 are affected.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0404-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0404-2021 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.
