Synthes recalls END RING 22mm x 28mm spinal implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects specific lot numbers for cervical, thoracic, and lumbar spine procedures.
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 (END RING 22mm x 28mm) 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 risks during surgical procedures.
The implants were incorrectly labeled as a general medical device on their statutory label instead of being classified as a specially controlled medical device. This mislabeling could result in improper regulatory oversight and potentially unsafe use during surgical procedures.
Patients who received the END RING 22mm x 28mm spinal implants with lot numbers 13L6742 or 14L2479 are likely affected. Surgeons and medical facilities using these specific implants for cervical, thoracic, or lumbar spine procedures are at highest risk.
Check for the END RING 22mm x 28mm spinal implant with product number 495-398. Look for lot numbers 13L6742 or 14L2479 on the packaging or device itself.
Look for the product number 495-398 and lot numbers 13L6742 or 14L2479 on the implant packaging or device.
The END RING 22mm x 28mm spinal implant (product number 495-398) used for cervical, thoracic, and lumbar spine procedures.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device on its statutory label.
Lot numbers 13L6742 and 14L2479.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0414-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0414-2021 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.
