Synthes recalls Standard Ring 22mm x 28mm (TI) implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling specific spinal implants because they're incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could impact how these implants are regulated and used in spinal surgery.
The implants are labeled incorrectly as a general medical device instead of a specially controlled medical device. This mislabeling could lead to improper regulatory oversight and potentially unsafe surgical practices.
Surgeons and patients who have received the Standard Ring 22mm x 28mm (TI) implants for spinal procedures are likely affected. Those using the implants in cervical, thoracic, or lumbar spine surgeries are at risk.
Check for the product name 'Standard Ring 22mm x 28mm (TI)' with product number 495-406. The implants were sold with lot numbers 19P7847, 20P1747, 21P3268, or H865134.
Look for the product number 495-406 on the implant packaging or device.
The product is incorrectly labeled as a general medical device instead of a specially controlled medical device, which could impact regulatory oversight.
The recall record does not specify a remedy, so no action is required at this time.
Lot numbers 19P7847, 20P1747, 21P3268, and H865134 are affected.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0416-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0416-2021 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.
