Synthes recalls END RING 17mm x 22mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units have specific product numbers and lot numbers.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling certain spinal implants because they 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 during medical procedures.
The implants were labeled incorrectly as a general medical device instead of a specially controlled medical device. This mislabeling could result in improper regulatory oversight and potential safety issues during medical procedures.
Patients who received the END RING 17mm x 22mm spinal implants with product number 495.394 and lot numbers 21P9197 or 47P8462 are affected. Surgeons and medical facilities using these implants are at risk.
Check for product number 495.394 and lot numbers 21P9197 or 47P8462 on the implant packaging or device. These are specific spinal implants used for cervical, thoracic, and lumbar spine replacements.
Look for product number 495.394 and lot numbers 21P9197 or 47P8462 on the implant packaging or device.
The implants were incorrectly labeled as a general medical device instead of a specially controlled medical device, which could lead to improper regulatory oversight.
Check the product label for product number 495.394 and lot numbers 21P9197 or 47P8462. If you have these, contact Synthes for further instructions.
The recall is due to labeling errors, not an immediate safety hazard. However, improper regulatory oversight could lead to potential safety issues during medical procedures.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0412-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0412-2021 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.
