Synthes recalls STANDARD RING 17MM X 22MM (TI) implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
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 spinal implant called the STANDARD RING 17MM X 22MM (TI) because it's incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could impact how the implant is regulated and used in spinal surgery.
The implant is incorrectly labeled as a 'general medical device' instead of a 'specially controlled medical device' on its statutory label. This mislabeling could lead to improper regulatory oversight and potentially affect surgical safety standards.
Surgeons and hospitals using this specific spinal implant for cervical, thoracic, or lumbar spine procedures are likely affected. Patients receiving this implant during surgery may be at risk if the labeling error impacts regulatory compliance.
Check for the product name 'STANDARD RING 17MM X 22MM (TI)' with product number 495-405. Look for lot numbers 25P6483 or 3L27511 on the packaging or documentation.
Verify the statutory label on the implant to confirm it correctly states 'specially controlled medical device' instead of 'general medical device'.
The implant is incorrectly labeled as a 'general medical device' instead of a 'specially controlled medical device' on its statutory label, which could impact regulatory oversight.
Check the labeling on the implant to confirm it correctly states 'specially controlled medical device'. If it's mislabeled, contact Synthes for guidance.
Look for the product name 'STANDARD RING 17MM X 22MM (TI)' with product number 495-405 and lot numbers 25P6483 or 3L27511.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0415-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0415-2021 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.
