Synthes recalls END RING 15MM DIA/0 DEG (TI) product 495.386 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 (END RING 15MM DIA/0 DEG (TI) with product number 495.386) 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 surgical procedures.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device. This mislabeling could result in the product being subject to different regulatory requirements than it should be, potentially affecting how it is used in surgical procedures.
Surgeons and medical facilities using the END RING 15MM DIA/0 DEG (TI) spinal implant product with specific lot numbers are affected. Patients receiving this implant during surgery may be at risk if the labeling error leads to incorrect regulatory handling.
Check for the product number 495.386 on the END RING 15MM DIA/0 DEG (TI) spinal implant. Affected units include specific lot numbers: 13L9586, 35P3375, 50P2547, and H861587.
Look for the product number 495.386 and specific lot numbers 13L9586, 35P3375, 50P2547, or H861587 on the implant.
The product number is 495.386 for the END RING 15MM DIA/0 DEG (TI) spinal implant.
Affected lot numbers are 13L9586, 35P3375, 50P2547, and H861587.
The product was recalled because it was incorrectly labeled as a general medical device instead of a specially controlled medical device.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0410-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0410-2021 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.
