Synthes recalls SYNMESH 22mm x 28mm 88mm height implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects spinal surgery implants sold in the US.
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 (SYNMESH 22mm x 28mm 88mm height) 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 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 misclassification could result in improper regulatory oversight and potential safety risks during surgical procedures. The labeling error might lead to inadequate quality control or handling protocols during implant use.
Patients who received the SYNMESH 22mm x 28mm 88mm height spinal implants from Synthes (USA) Products LLC are affected. Surgeons and medical facilities using these implants for spinal procedures are most at risk due to the labeling error.
Check for the SYNMESH 22mm x 28mm 88mm height (TI) product with the specific lot numbers: 10L8490, 17P3848, and M22. These implants are used for spinal procedures and were sold in the US.
Look for the product name, size, and lot numbers on the implant packaging or label.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device on its statutory label.
The official recall notice does not specify a remedy or action steps for affected products.
Lot numbers 10L8490, 17P3848, and M22 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-0407-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0407-2021 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.
