Synthes recalls END RING 17mm x 22mm spinal implants (product #495.392) due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific 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 (END RING 17mm x 22mm) 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 incorrectly labeled 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 surgical procedures.
Patients who received the END RING 17mm x 22mm spinal implants with lot numbers 43P3070, 45P9029, or 48P09506 are likely affected. Surgeons and medical facilities using these implants for spinal procedures are at risk.
Check for the product number 495.392 on the implant packaging. Look for lot numbers 43P3070, 45P9029, or 48P09506. The implants are used for cervical, thoracic, and lumbar spine replacements.
Look for the product number 495.392 and lot numbers 43P3070, 45P9029, or 48P09506 on the implant packaging.
The product was recalled because it was incorrectly labeled as a general medical device instead of a specially controlled medical device.
Check the product label for the product number 495.392 and lot numbers 43P3070, 45P9029, or 48P09506. If you have these, contact Synthes for further instructions.
The recall is due to labeling issues, not a direct risk of injury. However, improper regulatory oversight could lead to 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-0411-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0411-2021 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.
