Synthes recalls END RING 10MM DIA/0 DEG (TI) product due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers for cervical, thoracic, and lumbar spine 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 a specific spinal implant product because it was 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 misuse in medical procedures.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device. This mislabeling could result in improper regulatory oversight and potential misuse during surgical procedures.
Surgeons and medical facilities using the END RING 10MM DIA/0 DEG (TI) spinal implant product with lot numbers 10L6451 or 13L9584 are most at risk. Patients receiving this implant during surgery may be affected.
Check for lot numbers 10L6451 or 13L9584 on the END RING 10MM DIA/0 DEG (TI) spinal implant product. This product is used for cervical, thoracic, and lumbar spine replacements.
Look for lot numbers 10L6451 or 13L9584 on the END RING 10MM DIA/0 DEG (TI) product.
The END RING 10MM DIA/0 DEG (TI) spinal implant product used for cervical, thoracic, and lumbar spine replacements.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device.
Lot numbers 10L6451 and 13L9584.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0408-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0408-2021 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.
